{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5180790", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20251218", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20251218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1706791", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251218", "brand_name": "MAKO ROBOTIC SURGERY SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Data Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20251223", "health_professional": "*", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20251218", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "23838125", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "388019144", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "I AM WRITING IN RELATION TO MY MEDWATCH REPORT (REF: (B)(4)) AND THE ASSOCIATED FDA CDRH CASE REFERENCES (B)(4). I HAVE NOW FINALISED A CONSOLIDATED CROSS-JURISDICTIONAL REGULATORY NOTIFICATION CONCERNING MANUFACTURER-CONTROLLED DATA PATHWAYS AND UNAVAILABLE AUDIT TRAILS WITHIN THE MAKO SMART ROBOTICS SYSTEM, FOLLOWING THE NEW DISCLOSURES ISSUED BY (B)(6) HOSPITALS ON (B)(6) 2025." }, { "mdr_text_key": "388351606", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION ADDED ON 12/18/2025 FOR REPORT MW5180790 TO CREATE A FOLLOW-UP 1 REPORT. I AM WRITING TO PROVIDE A BRIEF UPDATE ON THE REGULATORY MATTERS PREVIOUSLY SUBMITTED TO YOU REGARDING MAKO SMART ROBOTICS DEVICE GOVERNANCE, CREDENTIALING OVERSIGHT, AND DATA INTEGRITY CONCERNS. FOLLOWING NICE¿S RESPONSE OF (B)(6) 2025, I HAVE NOW ISSUED A FORMAL REGULATORY ESCALATION LETTER DATED (B)(6) 2025, TOGETHER WITH A SUPPLEMENTARY REGULATORY QUESTION SUBMITTED ON 27 NOVEMBER 2025. THESE DOCUMENTS CLARIFY THE UNRESOLVED GOVERNANCE ISSUES, INCLUDING THE ABSENCE OF MAKO DEVICE LOGS, UNVERIFIED OPERATOR CREDENTIALING, AND CONTRADICTIONS ARISING FROM THE RECENT MAKO DATA DISCLOSURE PROVIDED BY THE TREATING HOSPITAL. THESE DOCUMENTS FORMALLY CLARIFY THE UNRESOLVED GOVERNANCE ISSUES PREVIOUSLY IDENTIFIED, I AM CURRENTLY AWAITING NICE¿S FORMAL RESPONSE AND WILL FORWARD THEIR REPLY TO YOU IMMEDIATELY UPON RECEIPT. RE: (B)(4) ¿ REQUEST FOR ASSOCIATE DIRECTOR¿LEVEL MTEP REVIEW, MHRA NOTIFICATION, AND POLICY CLARIFICATION. DEAR MS (B)(6), THANK YOU FOR YOUR LETTER DATED (B)(6) 2025. WHILE I APPRECIATE THE ACKNOWLEDGEMENT, YOUR RESPONSE DOES NOT ADDRESS THE MAJORITY OF THE REGULATORY, GOVERNANCE, AND SAFETY-CRITICAL CONCERNS I RAISED. I MUST ALSO NOTE AT THE OUTSET THAT WHEN I FIRST CONTACTED NICE, I WAS EXPRESSLY ASSURED THAT I WOULD RECEIVE A RESPONSE FROM AN ASSOCIATE DIRECTOR. THIS HAS NOT TAKEN PLACE. INSTEAD, MY CORRESPONDENCE WAS ROUTED TO THE GENERAL ENQUIRY HANDLING TEAM, WHICH IS NOT THE APPROPRIATE BODY TO ASSESS DEVICE MISUSE, GOVERNANCE FAILURES, OR CONCERNS RELATING TO NATIONAL EVIDENCE INTEGRITY. MY COMMUNICATIONS WERE ADDRESSED SPECIFICALLY TO MTEP, BECAUSE THE ISSUES I RAISE CONCERN: MISUSE OF A REGULATED ROBOTIC DEVICE; OPERATION BY AN UNREGISTERED AND UNSUPERVISED PRACTITIONER; BREACHES OF MANUFACTURER-MANDATED CREDENTIALING RULES; OMISSION OF CRITICAL INTRA-OPERATIVE INCIDENTS; FAILURES IN POST-MARKET SURVEILLANCE; CORRUPTION OF NATIONAL JOINT REGISTRY (NJR) DATA; UNDISCLOSED CONFLICTS OF INTEREST; NICE¿S 8-YEAR ABSENCE OF GUIDANCE ON ROBOTIC ORTHOPAEDICS; AND THE SAFETY IMPLICATIONS FOR MORE THAN 6,000 ELDERLY PATIENTS TREATED AT A SINGLE TRUST DURING THIS REGULATORY VACUUM. MISUSE OF A REGULATED MEDICAL DEVICE. AT THE TIME OF MY SURGERY ON (B)(6) 2025, MAKO SMART ROBOTICS REQUIRED: MAKO CERTIFICATION, RESTRICTED OPERATOR PERMISSION, CONSULTANT-LEVEL SUPERVISION, DOCUMENTED USER LOGS, COMPLIANCE WITH DEFINED CALIBRATION AND WORKFLOW STEPS. THESE REQUIREMENTS WERE NOT MET: IMPLANT LOGS SHOW DR (B)(6) AS THE OPERATING SURGEON. HE WAS NOT ON THE GMC REGISTER AT THE TIME (CONFIRMED BY THE GMC). NO SUPERVISING CONSULTANT IDENTIFIABLE AS PRESENT DURING CRITICAL STAGES. THE MAKO DEVICE WAS USED IN BREACH OF MANUFACTURER RULES. MISUSE OF A REGULATED DEVICE WITH RESULTING HARM IS A MANDATORY REPORTABLE EVENT UNDER: MHRA POST-MARKET SURVEILLANCE, AND U.S. FDA MEDWATCH REQUIREMENTS (21 CFR PART 803). MISUSE OF A REGULATED DEVICE WITH RESULTING HARM IS A NOTIFIABLE ADVERSE INCIDENT UNDER MHRA POST-MARKET SURVEILLANCE REQUIREMENTS. IT IS ALSO A MANDATORY REPORTABLE EVENT UNDER U.S. FDA MEDWATCH REQUIREMENTS (21 CFR PART 803). AS NICE HAS NOW BEEN NOTIFIED, AND AS YOU HAVE ACKNOWLEDGED NICE¿S OBLIGATION TO LIAISE WITH MHRA ON SAFETY CONCERNS, I REQUEST CONFIRMATION OF THE SAFETY NOTIFICATION NICE HAS MADE TO MHRA AND THE MHRA INCIDENT REFERENCE NUMBER. CARDIOVASCULAR EVENT ¿ REQUEST FOR EVIDENCE SOURCE. THE (B)(6) SAR DISCLOSURE SUPPORTS PERI-CARDIOVASCULAR EVENTS. YOUR LETTER ESCALATED THIS TERMINOLOGY TO ¿CARDIOVASCULAR COLLAPSE¿, AND I THEREFORE REQUEST THE SPECIFIC CLINICAL DOCUMENTATION RELIED UPON FOR THIS RECLASSIFICATION. OMISSION OF CRITICAL INTRA-OPERATIVE EVENTS; MY OPERATIVE RECORD OMITS: THE PERI-CARDIOVASCULAR COLLAPSE EPISODES, THE CAUSATION OF 42% SURGICAL DOWNSIZING OF MY PATELLA, DEVIATIONS FROM NORMAL IMPLANT PARAMETERS, OTHER ABNORMAL INTRA-OPERATIVE OBSERVATIONS. THESE OMISSIONS ARE NOT CLINICAL DISAGREEMENTS ¿ THEY ARE DATA-INTEGRITY FAILURES AFFECTING: NJR REPORTING, MAKO POST-MARKET SURVEILLANCE, INCIDENT REPORTING OBLIGATIONS, AND HTE22 EVIDENCE RELIABILITY, FUNDAMENTAL PATIENT SAFETY OBLIGATIONS. EIGHT-YEAR REGULATORY VACUUM ¿ HTE22 PUBLISHED 3 WEEKS AFTER MY SURGERY NICE PUBLISHED THE EARLY VALUE ASSESSMENT HTE22 ON (B)(6) 2025, THREE WEEKS AFTER MY SURGERY, FOLLOWING AN EIGHT-YEAR GAP WITH NO NICE GUIDANCE FOR ROBOT-ASSISTED JOINT REPLACEMENT. DURING THIS PERIOD: MAKO WAS ADOPTED WITH NO OVERSIGHT, NO TRAINING AUDITS EXISTED, NO CONFLICT-OF-INTEREST MECHANISMS EXISTED, NO GOVERNANCE FRAMEWORK EXISTED, THOUSANDS OF ELDERLY PATIENTS UNDERWENT ROBOTIC SURGERY WITH NO REGULATORY PROTECTION. I REQUEST CLARIFICATION ON WHAT PROMPTED NICE TO ISSUE GUIDANCE AT THIS JUNCTURE AFTER SUCH A PROLONGED ABSENCE. DESPITE THE PUBLICATION OF HTE22, THE CURRENT GUIDANCE DOES NOT ENSURE THAT TRUSTS REPORT COMPLICATIONS ACCURATELY, VERIFY OPERATOR TRAINING, OR DISCLOSE CRITICAL INCIDENTS. NICE¿S RECOMMENDATIONS STILL RELY ENTIRELY ON TRUST SELF-REPORTING, WHICH MY CASE DEMONSTRATES IS UNRELIABLE AND, IN PLACES, FACTUALLY INCORRECT. THIS MEANS THE GUIDANCE DOES NOT CURRENTLY PROTECT PATIENTS FROM EXACTLY THE RISKS IT WAS INTENDED TO ADDRESS. THE ABSENCE OF NICE GUIDANCE DOES NOT SUPERSEDE MANUFACTURER OPERATOR REQUIREMENTS. MAKO CERTIFICATION, CONSULTANT-LEVEL SUPERVISION, AND RESTRICTED OPERATOR PERMISSIONS WERE MANDATORY AT THE TIME OF MY SURGERY. THEIR BREACH CONSTITUTES DEVICE MISUSE AND A REPORTABLE SAFETY INCIDENT UNDER MHRA OBLIGATIONS. (B)(6) MAKO ACTIVITY ¿ 6,000+ PATIENTS TREATED WITHOUT OVERSIGHT NJR ACTIVITY DATA SHOWS: 2,050 MAKO CASES (2021¿24); 1,368 BY PROFESSOR (B)(6)¿ ALMOST 4× THE NATIONAL AVERAGE; AN ESTIMATED 6,000¿6,500 PATIENTS TREATED DURING THE 8-YEAR GUIDANCE VOID THE MAJORITY OF THESE PATIENTS ARE OLDER THAN 70 ¿ A VULNERABLE GROUP UNLIKELY TO CHALLENGE SURGICAL OUTCOMES NOR UNDERSTAND THE CONSEQUENCES OF MISREPORTED OUTCOMES OR RECOGNISE DEVICE-RELATED HARM. THESE PRACTISES DISPROPORTIONATELY AFFECT THE CLINICALLY VULNERABLE ELDERLY. ALL PASSED THROUGH AN EFFECTIVELY UNREGULATED PATHWAY. THIS EIGHT-YEAR REGULATORY VACUUM MEANT THAT MAKO WAS ADOPTED AT A SCALE UNPRECEDENTED IN THE UK, WITHOUT ANY NATIONAL OVERSIGHT, SAFETY FRAMEWORK, CREDENTIALING REQUIREMENT, OR MONITORING OF CONFLICTS OF INTEREST. IT WAS PRECISELY BECAUSE NICE LEFT THIS GAP UNADDRESSED FOR ALMOST A DECADE THAT THESE PATIENTS WERE EXPOSED TO UNNECESSARY RISK. GIVEN THIS ABSENCE OF REGULATORY CONTROL DURING A PERIOD OF HIGH-VOLUME MAKO ACTIVITY, NICE NOW HAS A DUTY TO ENSURE THAT THIS ENTIRE COHORT IS IDENTIFIED, REVIEWED AND FOLLOWED UP. NICE HAS A MORAL DUTY AND LEGAL DUTY TO ENSURE THIS ENTIRE COHORT ¿ AND ALL MAKO CENTRES OPERATING PRE-GUIDANCE ¿ ARE REVIEWED WITH REQUISITE URGENCY GIVEN THE DISPROPORTIONATE ADVANCED AGE OF THESE PATIENTS. INACCURATE NJR REPORTING ¿ EVIDENCE CONTAMINATION - MY NJR RECORD LISTS MY OUTCOME AS ¿SUCCESSFUL¿, DESPITE: INABILITY TO WALK, MECHANICAL INSTABILITY, HIP SUBLUXATION, RETAINED SUTURES, TENDON TRAUMA, LEG LENGTH DISCREPANCY, SEVERE PAIN, MRI-PROVEN ABNORMALITIES. THIS IS A FALSE NATIONAL RECORD AND DEMONSTRATES HOW THE EVIDENCE BASE FOR HTE22 IS ALREADY CONTAMINATED. REFLECTING INACCURATE TRUST-LEVEL REPORTING THAT DIRECTLY UNDERMINES THE VALIDITY OF NJR OUTPUTS RELIED UPON BY NICE. THIS MISINFORMATION IS ALREADY PERMEATING U.S. FDA SURVEILLANCE SYSTEMS (MAUDE/MEDWATCH), MEANING THE CONTAMINATION NOW AFFECTS INTERNATIONAL SAFETY EVALUATIONS. UNDECLARED FINANCIAL CONFLICTS OF INTEREST; BOTH PROFESSOR (B)(6) AND MR (B)(6) HAVE LONGSTANDING FINANCIAL RELATIONSHIPS WITH STRYKER, INCLUDING CONSULTANCY, TRAINING ROLES, INTERNATIONAL DEVICE PROMOTION, FACULTY POSITIONS, PROCTORSHIP, AND PAID INVOLVEMENT IN MAKO EXPANSION. MR (B)(6)¿S ACTIVE ROLE AS A STRYKER MAKO TRAINER IS EXTREMELY CONCERNING IN THIS CONTEXT. IN PROFESSOR (B)(6)¿S CASE, HIS FINANCIAL TIES DATE BACK NEARLY TWENTY YEARS (CIRCA 2007), PREDATING THE INTRODUCTION OF ROBOTIC SURGERY IN THE UK. THESE CONFLICTS ARE PUBLIC KNOWLEDGE. THEY ARE NOT OBSCURE OR HIDDEN FROM REGULATORY BODIES. YET, I WAS NOT INFORMED OF THEM AT ANY STAGE (PRE-OPERATIVE, INTRA-OPERATIVE OR POSTOPERATIVE), NICE¿S RESPONSE MADE NO REFERENCE AT ALL TO THIS ISSUE. THEIR FINANCIAL RELATIONSHIPS MATERIALLY AFFECT NATIONAL OUTCOME DATA, AS BOTH SURGEONS ARE AMONG THE HIGHEST-VOLUME MAKO OPERATORS IN THE UK. THIS RAISES FUNDAMENTAL QUESTIONS: WHY DID NICE MAKE NO ACKNOWLEDGEMENT OF THESE CONFLICTS IN YOUR RESPONSE, BEYOND STATING THAT NICE DOES NOT CHECK THEM? WHAT GUIDANCE DOES NICE HAVE IN PLACE TO ENSURE PATIENTS ARE INFORMED OF FINANCIAL CONFLICTS BEFORE CONSULTATION, EXAMINATION, CONSENT, OR SURGERY INVOLVING A DEVICE PROMOTED BY FINANCIALLY LINKED CLINICIANS? WHAT SAFEGUARDS DOES NICE APPLY TO PREVENT FINANCIAL RELATIONSHIPS FROM DISTORTING EVIDENCE FEEDING INTO NICE GUIDANCE (INCLUDING HTE22)? GIVEN THE COMMERCIAL NATURE OF MAKO ADOPTION AT (B)(6), AND THE EXTREME THROUGHPUT DEMONSTRATED IN NJR DATA, CONFLICT-OF-INTEREST OVERSIGHT IS NOT OPTIONAL ¿ IT IS FUNDAMENTAL TO GOVERNANCE, PATIENT SAFETY, AND EVIDENCE INTEGRITY. THE FAILURE TO DISCLOSE THESE FINANCIAL TIES MAKES IT IMPOSSIBLE FOR PATIENT CONSENT TO BE VALID, AS PATIENTS WERE NOT FULLY INFORMED ¿ AND THIS FAILING REMAINS THE CASE. NOW THAT THESE CONFLICTS HAVE BEEN BROUGHT TO NICE¿S ATTENTION. I REQUIRE CLARIFICATION ON WHETHER NICE CONSIDERS IT ACCEPTABLE FOR CLINICIANS WITH UNDISCLOSED FINANCIAL TIES TO PERSONALLY PROMOTE, ENDORSE, OR DELIVER SURGERY USING MAKO TECHNOLOGY MANUFACTURED BY STRYKER ¿ INCLUDING, SPECIFICALLY, PROFESSOR (B)(6) LONGSTANDING ROLE IN PROMOTING STRYKER INTERNATIONALLY. I FURTHER REQUEST NICE¿S FORMAL WRITTEN POLICY FOR FINANCIAL-CONFLICT DISCLOSURE, VERIFICATION, AND PATIENT NOTIFICATION, TOGETHER WITH CONFIRMATION OF NICE¿S POSITION NOW THAT THESE CONFLICTS HAVE BEEN CLEARLY HIGHLIGHTED. PLEASE PROVIDE THIS WITHIN 14 DAYS. SYSTEMIC GOVERNANCE FAILURE ¿ NO SAFETY NET FOR HARMED PATIENTS; SINCE (B)(6) 2025, I HAVE CONTACTED: GMC ¿ CQC - NHS ENGLAND ¿ PHSO ¿ NICE ¿ RCS - STRYKER, NO OVERSEEING BODY HAS PROVIDED A FUNCTIONING MECHANISM FOR A HARMED PATIENT WHOSE TRUST OBSTRUCTS AFTERCARE. CQC ADVISED ME TO ¿CONTACT ADULT SOCIAL CARE¿. TO MAKE THEM AWARE OF THE PRACTISES AT (B)(6). NHS ENGLAND CLAIMED THEY ONLY DEAL WITH RARE CONDITIONS, WHEN I RESPONDED ANTIPHOSPHOLIPID SYNDROME, IS A RARE CONDITION - STAFFING LEVELS WERE CITED AS A REASON NOT TO ADDRESS. THIS DEMONSTRATES A COMPLETE GOVERNANCE VACUUM. NICE¿S INCORRECT ASSUMPTION ABOUT MY TREATMENT SETTING: YOUR RESPONSE STATED NICE WAS UNSURE WHETHER MY SURGERY WAS NHS OR PRIVATE. IT WAS NHS SURGERY AT (B)(6). THIS INDICATES MY CORRESPONDENCE WAS NOT THOROUGHLY REVIEWED. OBSTRUCTION OF CARE, SINCE SURGERY, (B)(6) HAS: OBSTRUCTED ESSENTIAL IMAGING, OBSTRUCTED ACCESS TO FULL BLOOD PANELS, OBSTRUCTED ONWARD REFERRAL, OMITTED COMPLICATIONS FROM RECORDS, REFUSED FOLLOW-UP. THIS OBSTRUCTION DIRECTLY RELATES TO DEVICE MISUSE AND THE INVOLVEMENT OF AN UNREGISTERED OPERATOR. ADDITIONAL CLARIFICATION REQUESTED ¿ PROSPECTIVE RANDOMISED ROBOTIC STUDIES: COULD NICE PLEASE EXPLAIN, IN CLEAR LAYPERSON TERMS, THE DEFINITION OF A ¿PROSPECTIVE RANDOMISED STUDY¿ WHEN APPLIED TO ROBOTICALLY ASSISTED ARTHROPLASTY, AND OUTLINE THE PROTOCOLS THAT MUST EXIST FOR CLINICIANS AND PATIENTS IN SUCH CIRCUMSTANCES? CONCLUSION: THIS IS NOT AN INDIVIDUAL GRIEVANCE. IT IS A SYSTEMIC DEVICE-GOVERNANCE FAILURE INVOLVING: MISUSE OF MAKO, UNREGISTERED SURGICAL PRACTICE, SUPPRESSED INTRA-OPERATIVE INCIDENTS, CONFLICT-OF-INTEREST DISTORTIONS, CORRUPTED NATIONAL DATA, AND THOUSANDS OF ELDERLY PATIENTS EXPOSED DURING A REGULATORY VACUUM. GIVEN THE PUBLIC SAFETY IMPLICATIONS, I LOOK FORWARD TO YOUR CONFIRMATION THAT THIS MATTER WILL NOW BE HANDLED AT THE CORRECT (ASSOCIATE DIRECTOR) LEVEL. THE DISCLOSURE I HAVE RECEIVED SHOWS THAT: NO INDEPENDENT OPERATOR-CREDENTIALING FRAMEWORK EXISTS IN THE UK. TRUSTS RELY SOLELY ON STRYKER FOR CONFIRMATION OF SURGEON CERTIFICATION. PATIENTS, TRUSTS, AND REGULATORS CANNOT VERIFY TRAINING STATUS OR CONSOLE PRIVILEGES. DEVICE LOGS REQUIRED TO CONFIRM REAL-TIME SURGEON OPERATION MAY BE MISSING, OVERWRITTEN, OR UNAVAILABLE FOLLOWING SOFTWARE REINSTALL. THIS HAS CLEAR IMPLICATIONS FOR EVIDENCE VALIDITY, PROSPECTIVE RANDOMIZED STUDY METHODOLOGY, NATIONAL REGISTRY ACCURACY, AND POST-MARKET SURVEILLANCE RELIABILITY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/22/2025" } ] }