BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP

    MDR report key: 259078 · Received January 18, 2000

    Report

    Report Number
    1526439-2000-00002
    Event Type
    Other
    Date Received
    January 18, 2000
    Report Date
    January 17, 2000
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    HWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TAPPING THE PEDICLE, THE THREADED PART OF THE TAP BROKE OFF. THE BROKEN PART HAD TO BE REMOVED FROM THE PEDICLE, WHICH RESULTED IN EXTENDED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP TAP HWX DEPUY ACROMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other