BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL INTERVERTEBRAL BODY FIXATION

    MDR report key: 2972772 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01051
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    June 1, 2010
    Manufacturer
    SYNTHES (USA) WEST CHESTER, PA
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS TREATED BY DR (B)(6) GREATER THAN ONE YEAR AGO WITH 1 LEVEL NHANCE, L5-S1, BELOW A SCOLIOSIS IS HAVING ONGOING LEG PAIN, AND WAS KEEN TO HAVE HER INSTRUMENTATION REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76817 SPINAL INTERVERTEBRAL BODY FIXATION JDN SYNTHES (USA) WEST CHESTER, PA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other