BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEAD MALLET 7-1/2 W/NYLON CAPS

    MDR report key: 2274824 · Received September 20, 2011

    Report

    Report Number
    2274824
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    September 16, 2011
    Report Date
    September 20, 2011
    Manufacturer
    INTEGRA
    Product Code
    GFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING ACDF (ANTERIOR CERICAL DISKECTOMY AND FUSION), THE SURGEON WAS CHECKING THE SIZE OF SPACER NEEDED WITH TRIAL AND HANDLE. THE NYLON FACE OF THE MALLET BROKE OVER THE SURGICAL FIELD. ALL PIECES OF THE NYLON FACE WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEAD MALLET 7-1/2 W/NYLON CAPS NEUROSURGERY SURGICAL MALLET GFJ INTEGRA 19-796 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR