BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE

    MDR report key: 1323507 · Received February 20, 2009

    Report

    Report Number
    MW5010045
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 20, 2009
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ANTERIOR AND POSTERIOR FUSION OF L3-L5 WAS PERFORMED. WHILE PLACING ONE OF THE SCREWS, THE TIP OF THE SCREW DRIVER FRACTURED WITHIN THE SCREW HEAD. A 1.5 MM PIECE OF METAL WAS REMOVED FROM THE SCREW HEAD. DOSE OR AMOUNT: NA. DIAGNOSIS OR REASON FOR USE: TO IMPLANT SCREW FOR SPINAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SPINE SCREW DRIVER HXX SCREW DRIVER SHAFT NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR