BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ACE 4.5MM CORTICAL BONE SCREW

    MDR report key: 113537 · Received August 14, 1997

    Report

    Report Number
    2020311-1997-00035
    Event Type
    Malfunction
    Date Received
    August 14, 1997
    Report Date
    August 8, 1997
    Manufacturer
    DEPUY ACE MEDICAL COMPANY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DEPUY ACE TIBIAL NAIL WAS IMPLANTED ON 6/20/1996. SOMETIME BETWEEN JANUARY 1997 AND APRIL 1997, THE DISTAL MOST LOCKING SCREW BROKE. ON 4/22/97, THE SCREW WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ACE 4.5MM CORTICAL BONE SCREW Implant BONE SCREW HWC DEPUY ACE MEDICAL COMPANY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR