BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLS TOP SET-SCRW STR HAND DRV 7/32

    MDR report key: 1052272 · Received May 23, 2008

    Report

    Report Number
    1649384-2008-00275
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED DURING A KIT INSPECTION. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. PENDING INVESTIGATION.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING A KIT INSPECTION IT WAS IDENTIFIED THAT THE DRIVER WAS MISSING A PIECE OF METAL. ADD'L INFO RECEIVED VIA TELEPHONE FROM THE SALES REPRESENTATIVE. THE SALES REPRESENTATIVE REPORTED THAT DURING A KIT INSPECTION IT WAS IDENTIFIED THAT THE SMALL SCREW ON THE TOP OF THE HANDLE WAS MISSING. THE MALFUNCTION IS LIKELY TO CAUSE INTERVENTION IF IT WERE TO OCCUR DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLS TOP SET-SCRW STR HAND DRV 7/32 INCOMPASS KWQ ABBOTT SPINE 17RK

    Patients

    Seq Age Sex Outcome Treatment
    1