{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 58626 } }, "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": "2939274-2020-02045", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K981275", "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", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "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": "463248", "implant_date_year": "2004", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "2.0MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 10MM", "generic_name": "SCREW,FIXATION,BONE", "manufacturer_d_name": "WRIGHTS LANE SYNTHES USA PRODUCTS LLC", "manufacturer_d_address_1": "1302 WRIGHTS LANE EAST", "manufacturer_d_address_2": "", "manufacturer_d_city": "WEST CHESTER", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "19380", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "19380", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "401.160", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HWC", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Screw, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3040", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2020;05/20/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": [ "2.0MM TI MF CORTEX SCREW 10MM", " 2.0MM TI MF CORTEX SCREW 12MM", " 2.0MM TI MF CORTEX SCREW 6MM", " 2.0MM TI MF CORTEX SCREW 8MM", " UNK - PLATES", " UNK - PLATES", " UNK - PLATES", " UNK - SCREWS: CORTEX", " UNK - SCREWS: CORTEX", " UNK - SCREWS: CORTEX", " UNK - SCREWS: CORTEX", " UNK - SCREWS: CORTEX", " UNK - SCREWS: CORTEX" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "79", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hypersensitivity/Allergic reaction", "Injury", "Hypersensitivity/Allergic reaction", "Injury" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000302", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "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": "317357584", "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": "317357585", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS BEING TEST FOR LICHEN PLANUS AND HEARD OF TITANIUM LEAKING FROM SCREWS. THE SURGEON ASSUMPTION WAS THE 2.0MM CORTEX SCREWS, SELF-TAPPING 8MM TO 18MM LENGTH USED TO SECURE FACIAL IMPLANT IN MANDIBLE OR MIDFACE. UPON NOTIFICATION FROM CUSTOMER WE WENT THE ROUTE OF MEDICAL INFORMATION REQUEST THINKING THE PATIENT WAS INQUIRING ABOUT A FUTURE SURGERY WITH TITANIUM SCREWS BEING IMPLANTED NOT KNOWING THE PATIENT ALREADY THE SCREWS IMPLANTED IN A PREVIOUS SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TEN (10) DEVICES." }, { "mdr_text_key": "315374077", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS IS REPORT 4 OF 10 FOR (B)(4)." }, { "mdr_text_key": "315374078", "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. D2: ADDITIONAL DEVICE PRODUCT CODES: MQN, DZL, JEY. D11: ADDED THERAPY DATE. 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": "197120431", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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": "197120432", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS BEING TESTED FOR LICHEN PLANUS AND HEARD OF TITANIUM LEAKING FROM SCREWS. THE PATIENT HAD 2.0MM CORTEX SCREWS, SELF-TAPPING 8MM TO 18MM LENGTH USED TO SECURE FACIAL IMPLANT IN MANDIBLE OR MIDFACE FROM A PREVIOUS SURGERY. CONCOMITANT DEVICE: UNKNOWN PLATES: TRAUMA (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) 2.0MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 10MM. THIS IS REPORT 4 OF 4 FOR (B)(4)." } ], "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": "05/18/2020;05/26/2020" } ] }