BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEAD MALLET W/NYLON CAPS

    MDR report key: 2404344 · Received October 12, 2011

    Report

    Report Number
    2523190-2011-00074
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Report Date
    October 12, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    GFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH # (B)(4) - EVENT DESCRIPTION: DURING ACDF (ANTERIOR CERVICAL DISCECTOMY 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. ON (B)(6) 2011, CUSTOMER REPORTS NO PT HARM VIA PHONE. THE ORIGINAL INTENDED PROCEDURE: C2-C3, C3-C4 ANTERIOR CERVICAL DISCECTOMY, OSTEOPHYTECTOMY AND INSTRUMENTATION AND FUSION WITH TITANIUM GRAFTS. POSTERIOR CERVICAL LAMINECTOMY C2-C4 UNDER FLUOROSCOPIC GUIDANCE. DEVICE USAGE PROBLEM: (EG. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEAD MALLET W/NYLON CAPS M10 - ORTHOPEDIC GFJ INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR