BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: SPINE-US

    MDR report key: 12610368 · Received October 11, 2021

    Report

    Report Number
    8030965-2021-08597
    Event Type
    Injury
    Date Received
    October 11, 2021
    Report Date
    September 13, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNK - SCREWS: SPINE-US/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 0

    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. INTRAOP GENERAL COMPLICATIONS: 2 COMPLICATIONS WERE NOT DOCUMENTED. INTRAOP 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, STENOFIX, 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. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE (1) UNK - SCREWS: SPINE-US. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504869 UNK - SCREWS: SPINE-US SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention