BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH

    MDR report key: 12740002 · Received November 2, 2021

    Report

    Report Number
    8030965-2021-09232
    Event Type
    Injury
    Date Received
    November 2, 2021
    Report Date
    October 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    EZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: (B)(4): THIS REPORT IS FOR AN UNK VERTEBRAL BODY REPLACEMENT MESH: SYNMESH/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D3, H6 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 93 PATIENTS (52 FEMALE) WHO UNDERWENT INSTRUMENTATION SKYLINE BETWEEN (B)(6) 2006, AND (B)(6) 2020. IN 3 CASES IT WAS COMBINED WITH SYNAPSE POSTERIOR. 71 CASES WERE COMBINED WITH AN INTRACORPORAL CAGE, OF WHICH THERE ARE 1 CONCORDE, 1 SYNMESH, 1 CONFIDENCE CEMENT AND 68 NON-DEPUY BRANDS. EXCLUSION OF NON-DEPUY BRANDS WOULD REDUCE THE SAMPLE TO LESS THAN (B)(6), WHY DECISION WAS TAKEN TO ANALYZE THE WHOLE SAMPLE. MEAN AGE OF THE PATIENTS WAS (B)(6). INTRA-OPERATIVE COMPLICATIONS: 1 DURAL TEAR. 1 RECURRENT NERVE INJURY. POST-OP COMPLICATIONS WITHIN 1 YEAR: 14 DYSPHAGIA. 11 RECURRENT NERVE INJURY. 1 SSI SUPERFICIAL. READMISSIONS: 2 DRAIN HEMATOMA. 2 REDECOMPRESSION. 1 REVISION OF FUSION. GLOBAL ASSESSMENT OF NECK PAIN (GA) FAILURE %: FU 1 YRS.: 37 FU 2 YRS.: 36 GLOBAL ASSESSMENT OF ARM PAIN (GA) FAILURE %: FU 1 YRS.: 44 FU 2 YRS.: 52. THIS IS FOR DEPUY SYNTHES SYNMESH AND SYNAPSE POSTERIOR. THIS REPORT IS FOR ONE (1) UNK VERTEBRAL BODY REPLACEMENT MESH: SYNMESH. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Description of Event or Problem · 0

    THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 391 PATIENTS (377 FEMALES, MEAN AGE 52 YEARS) WHO UNDERWENT INSTRUMENTATION SKYLINE BETWEEN BETWEEN 2013 AND (B)(6) 2023. IN 7 CASES IT WAS COMBINED WITH SYNAPSE POSTERIOR. 439 CASES WERE COMBINED WITH AN INTERCORPORAL CAGE, OF WHICH THERE ARE 1 CONCORDE, 2 CERVIOS CAGE, 3 CONDUIT TLIF, 6 SYNMESH, 1 CONFIDENCE CEMENT, 88 CONDUIT CERVICAL, 67 SYNCAGE AND 271 NON-DEPUY BRANDS. THE CONDUIT CERVICAL (CC) CAGES IN THIS COHORT ARE PART OF A TOTAL OF 210 CC CAGES OF INTEREST TO ANALYZE SEPARATELY, SO THEY WILL BE EXCLUDED HERE. THIS LEAVES 391 CASES FOR ANALYSIS. COMPLICATIONS WERE REPORTED AS FOLLOWS: INTRA-OPERATIVE COMPLICATIONS: 3 PATIENTS HAD DURAL INJURY. 1 PATIENT HAD VOCAL CORD DYSFUNCTION. 2 PATIENTS HAD BLOOD VESSEL INJURY. 1 PATIENT HAD HEMATOMA. 1 PATIENT HAD ESOPHAGUS INJURY. 1 PATIENT DEATH. POST-OP COMPLICATIONS WITHIN 1 YEAR: 85 PATIENTS HAD DYSPHAGIA. 59 PATIENTS HAD VOCAL CORD DYSFUNCTION. 7 PATIENTS HAD SURGICAL SITE INFECTION. 1 PATIENT HAD PULMONARY EMBOLISM. 1 PATIENT HAD THROMBOSIS. REASONS FOR REOPERATIONS: 5 PATIENTS HAD HEMATOMA DRAIN. 5 PATIENTS HAD REDECOMPRESSION. 1 PATIENT HAD REVISION OF FUSION. 1 PATIENT HAD DRAIN OF INFECTION. 1 PATIENT HAD REPAIR OF DURAL INJURY. 1 PATIENT HAD REOPERATION DUE TO OTHER REASONS. 1 PATIENT HAD 2ND REOPERATION TO DRAIN INFECTION. THIS REPORT IS FOR UNKNOWN SYNTHES SYNMESH THIS REPORT CAPTURES THE FOLLOWING ADVERSE EVENTS: INTRA-OPERATIVE COMPLICATIONS: 3 PATIENTS HAD DURAL INJURY. 1 PATIENT HAD VOCAL CORD DYSFUNCTION. 2 PATIENTS HAD BLOOD VESSEL INJURY. 1 PATIENT HAD HEMATOMA. 1 PATIENT HAD ESOPHAGUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635752 UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH SURGICAL MESH EZX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention