{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 761993 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "8030965-2020-03109", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K142838", "date_of_event": "20200408", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466942", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "4.0MM TI CANCELLOUS POLYAXIAL SCREW 24MM FOR 4.0MM RODS", "generic_name": "ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION", "manufacturer_d_name": "OBERDORF SYNTHES PRODUKTIONS GMBH", "manufacturer_d_address_1": "EIMATTSTRASSE 3", "manufacturer_d_address_2": "", "manufacturer_d_city": "OBERDORF", "manufacturer_d_state": "", "manufacturer_d_zip_code": "4436", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "4436", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "04.615.124", "lot_number": "H726350", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200428", "device_report_product_code": "NKG", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07611819477230", "udi_public": "(01)07611819477230", "openfda": { "device_name": "Posterior Cervical Screw System", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3075", "device_class": "2" } } ], "product_problems": [ "Compatibility Problem", "Compatibility Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2020;05/13/2020;05/27/2020;06/19/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20200427", "sequence_number_treatment": [ "UNK - SCREWDRIVERS" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20200408", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000160", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "316703561", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: MANUFACTURING LOCATION: BRANDYWINE / PACKAGED AND RELEASED BY: MONUMENT RELEASE DATE: SEPTEMBER 21, 2018, EXPIRATION DATE: SEPTEMBER 1, 2028. PART NUMBER: 04.615.124S 4.0MM TI CANCELLOUS POLYAXIAL SCREW 24MM FOR 4.0MM ROD (STERILE) LOT NUMBER: H737803, LOT QUANTITY: 23. NOTE: MONUMENT ONLY COMPLETES A THERMAL RINSE AND PACKAGING OPERATION FOR THIS PART NUMBER. THE ACTUAL MANUFACTURE OF THIS PART IS PERFORMED BY THE BRANDYWINE FACILITY. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE PACKAGING OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT(S) REVIEWED: COMPONENT PART REVIEW FOR PART NUMBER 04.615.014Y LOT NUMBER H726350 AND RELEVANT SUB-COMPONENTS NEEDS TO BE ASSIGNED TO THE BRANDYWINE DHR REVIEW TEAM BRANDYWINE DHR REVIEW PART NUMBER: 04.615.124Y, LOT NUMBER: H726350, DATE OF MANUFACTURE: SEPTEMBER 5, 2018, PLACE OF MANUFACTURE: BRANDYWINE, PART EXPIRATION DATE: N/A (NONSTERILE) LIST OF NONCONFORMANCES: NONE. DESCRIPTION OF DHR REVIEW: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT ACTION. BRANDYWINE DHR REVIEW DESCRIPTION OF DHR REVIEW: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT ACTION. THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE CANCELLOUSSCR SYNAPSE Ø4 L24 F/R Ø4 TAN (PART # 04.615.124/ LOT #H726350) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). THE HEAD OF THE CANCELLOUS SCREW SHANK SHOWED EXTENSIVE DAMAGE. THE HEX-LOBES OF THE T-15 RECESS WERE STRIPPED/WORN AS THE LOBES WERE FLATTENED. SCRATCHES WERE ALSO PRESENT ON THE MOST DISTAL PART OF THE HEAD AS THERE WERE CIRCULAR SCRATCHES ON THE INSIDE FACE. FUNCTIONAL TEST: FUNCTIONAL TESTING COULD NOT BE PERFORMED AS NO MATING DEVICES WERE RETURNED WITH THE SCREWDRIVER. DUE TO THE NOTED STRIPPED CONDITION OF THE SCREW HEAD, THE OVERALL COMPLAINT OF UNABLE TO ASSEMBLE CAN BE CONFIRMED. BECAUSE OF THE OBSERVED DAMAGE, THE SCREW HEAD CANNOT PROPERLY MATE WITH A RELEVANT SCREWDRIVER. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. THE SCREW HEAD COULD NOT BE ACCESSED WITHOUT DESTRUCTION OF OTHER DEVICE COMPONENTS. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: CURRENT & MANUFACTURED REVISIONS ASSEMBLY SCREW COMPONENT CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED CANCELLOUSSCR SYNAPSE Ø4 L24 F/R Ø4 TAN AS THE HEX-LOBES WERE STRIPPED. DEEP SCRATCHES WERE HEAVILY PRESENT ON THE INSIDE FACE. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED ITS POSSIBLE THE SCREW EXPERIENCED UNINTENDED FORCES WHILE ATTEMPTING TO BE UTILIZED WITH THE RELEVANT MATING SCREWDRIVER. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "316703562", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT OUTCOME WAS REPORTED AS STABLE." }, { "mdr_text_key": "193953231", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL PROCODES: KWP, MNH, MNI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "193953232", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A POSTERIOR CERVICAL SPINAL FUSION IN C1-C2 TREATING ATLANTOAXIAL SUBLUXATION OCCURRED ON (B)(6) 2020. WITH THE HELP OF IMAGING, THE SURGEON TRIED TO INSERT THE SCREW IN C2 WHICH WAS CONNECTED WITH A SCREWDRIVER. HALFWAY THROUGH THE INSERTION, THE CONNECTION BETWEEN THE SCREW AND THE SCREWDRIVER BECAME OUT OF LINE, AND INSERTION DIRECTION CHANGED. THE SURGEON RETRACTED THE SCREW AND RETRIED INSERTION. BUT THE EVENT RECURRED. THE SURGEON USED ANOTHER SCREW. THIS TIME, CONNECTION BETWEEN THE DEVICES WAS A LITTLE OFF, BUT INSERTION WAS COMPLETED SUCCESSFULLY. A SURGICAL DELAY OF LESS THAN 30-MINUTE WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4)." }, { "mdr_text_key": "315938343", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "315953915", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "315130096", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." } ], "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": "05/12/2020;05/14/2020;06/04/2020;06/22/2020" } ] }