BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 1914297 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01538
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    August 6, 2009
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO BRAND NAME, CATALOG NUMBER OR LOT NUMBERS WERE PROVIDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. NEITHER THE DEVICE NOR TEST RESULTS NOR IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BACK PAIN DIRECTLY OVER HARDWARE 13 MONTHS POST BILATERAL POSTEROLATERAL FUSION WITH INSTRUMENTATION AND ILIAC CREST BONE GRAFT. HARDWARE WAS SUSPECTED TO BE CAUSING THE SYMPTOMS. A CT SCAN DID NOT SHOW ANY EVIDENCE OF NON-UNION. FUSION EXPLORATION WAS PERFORMED FOUR DAYS LATER, AT WHICH TIME A FRACTURED PEDICLE SCREW WAS NOTED - NO DETAILS ARE GIVEN. NO COMPLICATIONS WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Required Intervention