BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA ANTERIOR LUMBAR PLATE SYSTEM

    MDR report key: 842058 · Received April 16, 2007

    Report

    Report Number
    2184052-2007-00008
    Event Type
    Injury
    Date Received
    April 16, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 16, 2007
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE DEVICES WERE RETURNED FOR ANALYSIS AND NO MANUFACTURING DISCREPANCIES WERE IDENTIFIED. THE TRINICA ALP INSTRUCTIONS FOR USE (07.01085.001 REV C) STATES IN THE ADVERSE EFFECTS SECTION, "BONE FRACTURE OR STRESS SHIELDING AT, ABOVE, OR BELOW THE LEVEL OF SURGERY. LOT 60540349 (MFG DATE 12-2006); LOT 60527385 (MFG DATE 08/2006).

    Description of Event or Problem · 1

    ORIGINAL SURGERY IN 2007. PATIENT RECEIVED 35MM 16 DEGREE TRINICA ANTERIOR LUMBAR PLATE, FOUR 5.5X24MM FIXED SCREWS AND ANOTHER MANUFACTURES INTERBODY DEVICE AT 14/5. DURING A FOLLOW UP EXAMINATION BETWEEN THE SURGERON AND PATIENT X-RAYS REVEALED A FRACTURE OF THE L5 VERTEBRAL BODY. REVISION SURGERY PERFORMED NINE DAYS LATER, TO REMOVE THE PLATE, SCREWS AND INTERBODY DEVICE. IT WAS REPORTED AT L4/5 SPACE COLLAPSED. A 37MM 65 DEGREE TRINICA ANTERIOR SACRAL PLATE AND 4 FIXED SCREWS TWO 34MM AND TWO 30MM SCREWS) WERE INSERTED AND THE DISC SPACE WAS FILLED WITH BONE CHIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA ANTERIOR LUMBAR PLATE SYSTEM 5.5X24MM FIXED SCREW KWQ ZIMMER SPINE, INC. 07.01013.002 60540349, 60527385

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other