BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1912338 · Received December 2, 2010

    Report

    Report Number
    1030489-2010-01520
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITONAL INFORMATION: IMAGING FILMS SUPPLIED FOR REVIEW SHOW PEDICLE SCREWS WITH RODS AT L3-L4-L5. ONE OF THE LOWER LEVEL SCREWS (L5) IS FRACTURED MID PEDICLE. NO INTERBODY DEVICES ARE NOTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. DEVICES THAT ARE ASSOCIATED WITH THIS EVENT ARE 7226545 X 2, 7225550 X 3, 7226550 X 1, 7220850 X 6 AND 7893080 X 2. MANUFACTURE DATE FOR PART # 7893080, LOT W08J0596 IS 09/04/2008.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE BROKEN SCREW REMOVED. THE SCREW AT L5 WAS ALSO REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT L3-5. SOMETIME POST-OP DURING A ROUTINE FOLLOW UP, IT WAS FOUND THAT THE SCREWS AT L5 HAD BROKEN. THE PATIENT REPORTED HAVING LOWER BACK PAIN. THE PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY IN THE NEAR FUTURE. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention