{ "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": 178747 } }, "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": "8030965-2020-03112", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "UK", "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": "464734", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "UNK - CONSTRUCTS: PLATE/SCREWS", "generic_name": "PLATE, FIXATION ,BONE   ", "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": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HRS", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "8030965" ], "fei_number": [ "3002807305" ], "device_name": "Plate, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250815", "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": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "No Code Available", "Unspecified Infection", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000735", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "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": "196746087", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN PLATE/ SCREW CONSTRUCT/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN MARCH 2014 TO MAY 2016. 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. (B)(4). 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. (B)(4)." }, { "mdr_text_key": "196746088", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: IQBAL, H.J. ET AL. (2018), EARLY SURGICAL STABILIZATION OF COMPLEX CHEST WALL INJURIES IMPROVES SHORT-TERM PATIENT OUTCOMES, THE JOURNAL OF BONE AND JOINT SURGERY, VOL. 100-A, NUMBER 15, PAGES 1298-1308, (UNITED KINGDOM). THE AIM OF THIS STUDY WAS TO CONDUCT A REVIEW OF ALL PATIENTS RECEIVING INTERNAL FIXATION OF COMPLEX RIB FRACTURES WITHIN OUR MAJOR TRAUMA CENTER. WE AIMED TO DETERMINE VARIOUS FACTORS AFFECTING THE OVERALL SHORT-TERM OUTCOMES OF THE SURGICAL INTERVENTION FOR THESE INJURIES AND TO ANALYZE WHETHER EARLY SURGICAL INTERVENTION AFFECTED POSTOPERATIVE OUTCOMES. FROM MARCH 2014 TO MAY 2016, A TOTAL OF 102 PATIENTS WITH RIB FRACTURES WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF THE RIBS WERE INCLUDED IN THE STUDY. THERE WERE 66 MALES AND 36 FEMA,ES WITH A MEDIAN AGE OF 62 YEARS (RANGE, 20 TO 93 YEARS). THE IMPLANTS USED WERE THE MATRIXRIB TITANIUM RIB FRACTURES FIXATION SYSTEM (DEPUY SYNTHES) WITH 3 BICORTICAL LOCKING SCREWS ON EITHER SIDE OF THE FRACTURE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS DIED, 1 IN THE EARLY SURGICAL PROCEDURE GROUP (DUE TO A SEVERE HEAD INJURY) AND 2 IN THE LATE SURGICAL PROCEDURE GROUP (1 BECAUSE OF MYOCARDIAL INFARCTION A FEW WEEKS AFTER DISCHARGE AND 1 BECAUSE OF PNEUMONIA 3 WEEKS AFTER DISCHARGE TO A PERIPHERAL HOSPITAL). 1 PATIENT HAD POSTOPERATIVE SUPERFICIAL WOUND INFECTION TREATED WITH ANTIBIOTICS. 2 PATIENTS HAD SEROMAS, 1 TREATED SURGICALLY. 29 PATIENTS DEVELOPED PNEUMONIA REQUIRING ANTIBIOTICS. 1 PATIENT DEVELOPED PNEUMOTHORAX AFTER CHEST DRAIN REMOVAL. THIS REPORT IS FOR THE MATRIXRIB TITANIUM RIB FRACTURES FIXATION SYSTEM (DEPUY SYNTHES) WITH 3 BICORTICAL LOCKING SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE/ SCREW CONSTRUCT. THIS IS REPORT 1 OF 1 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": "" } ] }