BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP

    MDR report key: 278017 · Received May 12, 2000

    Report

    Report Number
    1526439-2000-00007
    Event Type
    Other
    Date Received
    May 12, 2000
    Report Date
    May 12, 2000
    Manufacturer
    DEPUY ACROMED INC
    Product Code
    HWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS RECEIVED, THE 5.5MM TAP BROKE OFF IN THE PEDICLE SCREW DURING INSERTION. THE BROKEN PIECE OF THE TAP WAS VERY DIFFICULT TO REMOVE FROM THE PEDICLE SCREW. SURGERY TIME WAS PROLONGED BY OVER 1/2 HOUR DUE TO THIS EVENT. THE BROKEN INSTRUMENT IS CURRENTLY BEING EXAMINED TO DETERMINE THE CAUSE OF THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP 5.5 MM TAP HWX DEPUY ACROMED INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other