BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ACIS

    MDR report key: 12606348 · Received October 11, 2021

    Report

    Report Number
    8030965-2021-08561
    Event Type
    Injury
    Date Received
    October 11, 2021
    Report Date
    September 13, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CONSTRUCTS: ACIS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. INITIAL REPORTER IS A J&J REPRESENTATIVE. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS WHO WERE TREATED WITH DEPUY SYNTHES SPINE LLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED AS PER THE SPINE TANGO REPORT: 2 PATIENTS DIED. INTEROP GENERAL COMPLICATIONS: 2 COMPLICATIONS WERE NOT DOCUMENTED. INTEROP ADVERSE EVENTS: 6 COMPLICATIONS WERE DURAL LESIONS. 2 COMPLICATIONS WERE VASCULAR INJURY. 2 COMPLICATIONS WERE FRACTURE VERTEBRAL STRUCTURES. 2 WERE OTHER COMPLICATIONS. POSTOP GENERAL BEFORE DISCHARGE: 3 COMPLICATIONS WERE CARDIOVASCULAR. 1 COMPLICATION WAS PULMONARY. 1 COMPLICATION WAS THROMBOEMBOLISM. 3 COMPLICATIONS WERE NOT DOCUMENTED. POSTOP SURGICAL BEFORE DISCHARGE: 1 COMPLICATION WAS SENSORY DYSFUNCTION. 1 COMPLICATION WAS WOUND INFECTION SUPERFICIAL. 11 WERE OTHER COMPLICATIONS. 3 COMPLICATIONS WERE NOT DOCUMENTED. REOPERATIONS: 4 PATIENTS HAD REOPERATIONS. THIS REPORT IS FOR AN UNKNOWN ACIS, CERVIOS, CERVIOS CHRONOS, CHRONOS, CSLP, FACET WEDGE, ECD, MATRIX, OPAL, ORACLE, STENO FIX, SYNAPSE, SYNEX, SYNFIX EVOLUTION, SYNFLATE, SYNMESH, T-PAL, USS SMALL STATURE, USS, USS FRACTURE, USS FX MIS, VECTRA, VBS, VERTECEM, XRL, ZERO-P, ZERO-P VA. THIS REPORT IS FOR (1) UNK - CONSTRUCTS: ACIS. THIS REPORT IS 12 OF 20 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502498 UNK - CONSTRUCTS: ACIS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention