BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK LORDOTIC

    MDR report key: 1485815 · Received July 28, 2009

    Report

    Report Number
    2184052-2009-00060
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    January 29, 2008
    Report Date
    February 18, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THIS MDR IS BEING SUBMITTED LATE AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES CONDUCTED IN-CONJUNCTION WITH IMPLEMENTATION OF REVISED MDR REPORTING CRITERIA FOR ZIMMER.

    Description of Event or Problem · 1

    AFTER INSERTING THE BAK PROXIMITY CAGE, THE SURGEON WAS USING THE INSERTER WITHOUT THE DRILL TUBE TO REPOSITION THE FIRST CAGE AT WHICH TIME ONE OF THE PRONGS BROKE OFF THE DRIVER. THE BROKEN PORTION WAS RETRIEVED WITH NO PATIENT INJURY REPORTED. NO ADDITIONAL SURGERY TIME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK LORDOTIC IMPLANT DRIVER, 11MM HXX ZIMMER SPINE, INC. 07.00011.001 P010850

    Patients

    Seq Age Sex Outcome Treatment
    1