BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD METAGLENE V3.2

    MDR report key: 693582 · Received March 27, 2006

    Report

    Report Number
    1818910-2006-01004
    Event Type
    Malfunction
    Date Received
    March 27, 2006
    Date of Event
    March 2, 2006
    Report Date
    March 2, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE THREADS ON THE METAGLENE AND THE THREADS FROM THE LOCKING SCREWS DIDN'T ENGAGE CORRECTLY AND CROSS THREADED. SURGERY WAS EXTENDED APPROX 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD METAGLENE V3.2 TOTAL SHOULDER REPLACEMENT KWR DEPUY FRANCE S.A. NA 1891585

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR