BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY HEX DRIVER, RING RETAINER

    MDR report key: 1633691 · Received March 3, 2010

    Report

    Report Number
    2184052-2010-00002
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEWED. DEVICE HISTORY RECORD CONFIRMS THAT DEVICE WAS MANUFACTURED TO SPECIFICATION AND REQUIREMENTS. ADDITIONAL INVESTIGATION OF THE INSTRUMENT IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    DURING SURGERY, WHILE IMPLANTING THE SCREW, THE DRIVER WOULD NOT RELEASE OFF THE SCREW. THE SCREW WAS REMOVED FROM THE PT AND ALTERNATE SCREW DRIVER WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY HEX DRIVER, RING RETAINER SPECIALTY HEX DRIVER, RING RETAINER HXX ZIMMER SPINE, INC. 07.00501.701 P080806

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR