BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIGID PLATE TWO LEVEL

    MDR report key: 1241769 · Received November 20, 2008

    Report

    Report Number
    2530088-2008-00063
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 22, 1988
    Report Date
    October 28, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K063158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED. A DHR REVIEW HAS BEEN REQUESTED AND IS IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    DURING A L3 CORPECTOMY, SURGEON WAS IMPLANTING A TWO LEVEL, (6) HOLE PLATE. THE SCREWS DID NOT LOCK DOWN AND THE SURGEON REMOVED (5) SCREWS WITH THE 6TH SCREW WELDING TO THE PLATE UPON ATTEMPTED REMOVAL. SURGEON REMOVED THE PLATE AND THE SCREW TOGETHER CAUSING MORE THAN MODERATE DAMAGE TO THE VERTEBRAL BODY. PT WAS REVISED TO LONGER PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI RIGID PLATE TWO LEVEL TI ANTEGRA PLATES KWQ SYNTHES (USA) NA 5650614

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS