BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CERVICAL SPINE LOCKING PLATE VARIABLE ANGLE

    MDR report key: 1233856 · Received November 13, 2008

    Report

    Report Number
    2520274-2008-00099
    Event Type
    Injury
    Date Received
    November 13, 2008
    Report Date
    October 17, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR A HEMATOMA, THE SURGEON NOTED ONE SCREW BACKING OUT FROM THE LOCKING PLATE WHICH WAS PLACED DURING A PREVIOUS ACDF PROCEDURE. THE SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CERVICAL SPINE LOCKING PLATE VARIABLE ANGLE LOCKING PLATE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS