BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OCCIPITAL PLATE-MEDIAL

    MDR report key: 1013122 · Received March 14, 2008

    Report

    Report Number
    1719045-2008-00020
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K072434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A TI OCCIPITAL PLATE - MEDIAL, IMPLANTED FOR AN OCCIPITAL-CERVICAL FUSION FROM OCCIPUT TO C5, BROKE POST OPERATIVELY. THE LATERAL WING OF THE PLATE BROKE COMPLETELY OFF. THE 3 OCCIPITAL SCREWS REMAINED INTACT WITH GOOD PURCHASE. THE RODS REMAINED UNBROKEN AS WELL. THE BROKEN PLATE WAS REMOVED AND REPLACED WITH THE SAME PLATE. IT IS BELIEVED THE PT WAS INVOLVED IN A CAR ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI OCCIPITAL PLATE-MEDIAL NONE HRS SYNTHES (USA) NA 1598486

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| RODS