{ "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": "SUITE 3300", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MONTREAL, QUEBEC", "manufacturer_contact_address_1": "56 E. BELL DR.", "manufacturer_contact_pcity": "57452603", "event_type": "Injury", "report_number": "0009617840-2026-00006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260211", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20240624", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745260384", "noe_summarized": "1", "manufacturer_contact_l_name": "RAPSAVAGE", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260211", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20200903", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "375151", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260211", "brand_name": "ROSA RECON PLATFORM 110V", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "ZIMMER CAS", "manufacturer_d_address_1": "75 QUEEN STR.", "manufacturer_d_address_2": "SUITE 3300", "manufacturer_d_city": "MONTREAL, QUEBEC", "manufacturer_d_state": "", "manufacturer_d_zip_code": "H3C 2", "manufacturer_d_zip_code_ext": "N6", "manufacturer_d_country": "CA", "manufacturer_d_postal_code": "H3C 2N6", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "20802010001", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00889024511170", "udi_public": "(01)00889024511170(11)200903", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260417", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "N6", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260211", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Notching" ] } ], "distributor_city": "", "date_report": "20260211", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "24316286", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240701", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "H3C 2", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ZIMMER CAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "392721526", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). LOG FILES RELATED TO THE REPORTED EVENT WERE UNABLE TO BE RETURNED FOR INVESTIGATION. AS SUCH, THE INFORMATION CLARIFYING THE COMPLAINT EVENT PROVIDED CANNOT BE CONFIRMED. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) FOR AN UNRELATED ERROR MESSAGE AT LAUNCH. THE FSE DID NOT FIND EVIDENCE OF ACCURACY ISSUE WITH THE ROSA PLATFORM. AFTER THE MAINTENANCE, THE PLATFORM WAS FOUND READY FOR CLINICAL USE. THE SERIAL NUMBER WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE SERVICING/MAINTENANCE PROCESS CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE WITH THE OBLONG HOLE FROM THE REAMER COULD NOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS." }, { "mdr_text_key": "392721527", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "75 QUEEN STR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }