BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SPINE

    MDR report key: 1469314 · Received August 28, 2009

    Report

    Report Number
    MW5012628
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 27, 2009
    Manufacturer
    DEPUY SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANTERIOR/POSTERIOR SPINAL FUSION REVISION DECOMPRESSION USED BY A DR, ORTHO SURGEON, TIP OF SCREW DRIVER ACCIDENTALLY BROKE OFF. DR FELT IT WAS SAFER FOR PT TO LEAVE TIP IN THE SCREW HEAD RATHER THAN TRY TO REMOVE IT, SO HE LEFT IT IN "AND IMPLANT ROD PLACED ON TOP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE SI POLYAXIAL SCREW DRIVER HXX DEPUY SPINE 2797-12-400 0209MI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention