BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 3863633 · Received June 10, 2014

    Report

    Report Number
    1030489-2014-02720
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMS THE BONE SCREW DISASSEMBLED FROM THE HEAD. THE RING AND CROWN WERE STILL ASSEMBLED IN THE HEAD. A PORTION OF THE RING HAS BEEN SHEARED OFF, WITH THE REMAINING PORTION OF RING STILL SEATED IN THE GROOVE OF THE HEAD. THE BONE SCREW HEAD DIAMETER HAS BEEN INSPECTED, AND FOUND TO BE WITHIN PRINT SPECIFICATION. THE RETAINING RING IS FULLY SEATED, BUT HAS BEEN PARTIALLY SHEARED OFF. A BROKEN PORTION OF THE RING IS SPLIT AND BENT OUT OF THE RING GROOVE. THE SHEARED PORTIONS ARE ON EITHER SIDE OF THE RETAINING RING GAP, WHICH COULD REDUCE FORCE REQUIRED FOR RING FAILURE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD AS THE MECHANISM OF FAILURE.

    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 SURGERY A MINIMALLY INVASIVE TRANSFORAMINAL INTERBODY FUSION AT L5-S1. APPROXIMATELY 6 WEEKS POST-OP PATIENT UNDERWENT A REVISION SURGERY DUE TO A SCREW HEAD COMING OFF OF THE SCREW POST. THE BONE SCREW AS WELL AS THE SET SCREW AND ROD WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337864 N/A APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA W08J1303

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention SET SCREW, ROD