BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECEPT TRAY

    MDR report key: 3775727 · Received April 22, 2014

    Report

    Report Number
    MW5035787
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 21, 2014
    Manufacturer
    NUVASIVE
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LUMBAR 5- SACRAL 1 ALIF PERFORMED. PT FLIPPED PRONE TO PROCEED WITH L5-S1 PERCUTANEOUS PEDICLE SCREW FIXATION. K-WIRE PLACED INTO VERTEBRAL BODY SACRAL ONE, SCREW PLACED OVER THE K-WIRE AND INTO THE VERTEBRAL BODY. XRAY TAKEN, K-WIRE NOTED TO BE BENT AT A RIGHT ANGLE, SLAP HAMMER FOR K-WIRE UTILIZED TO REMOVE WIRE. TIP OF K-WIRE BROKE OFF INTO VERTEBRA BODY SACRAL ONE UPON REMOVING THE K-WIRE. DR (B)(6) AWARE AND UPON HIS CLINICAL DECISION HAS DECIDED TO LEAVE IT IN THE S1 VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244074 PRECEPT TRAY STAINLESS STEEL K-WIRE HXI NUVASIVE PART # 8801000

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention