BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACF DISTRACTION SCREW 12MM ONE

    MDR report key: 1245469 · Received November 7, 2008

    Report

    Report Number
    2430952-2008-00034
    Event Type
    Other
    Date Received
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INSTRUMED INTERNATIONAL
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMNER SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THAT THE R6367A WHICH IS SUPPOSED TO BE A 12 MM DISTRACTION SCREW IS REALLY A 16 MM, AND IS THEREFORE MISLABELED. THEY OPENED AN THEN DISCARDED 2 SCREWS AND KEPT THE THIRD FOR EVAL. THEY HAD OTHER SCREWS ON HAND TO USE FOR PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF DISTRACTION SCREW 12MM ONE VERTEBRAL BODY DISTRACTION SYSTEM MQP INSTRUMED INTERNATIONAL 326081

    Patients

    Seq Age Sex Outcome Treatment
    1