BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 3785123 · Received May 1, 2014

    Report

    Report Number
    1030489-2014-02390
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL REVIEW CONFIRMS SHAFT FRACTURE. THE HELICAL MORPHOLOGY OF THE FRACTURE, WHICH APPEARS TO FOLLOW THE BASE OF THE THREAD, AS THE RIVERLINES SUGGEST TORSIONAL OVERLOAD AS THE MECHANISM OF FAILURE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT "WE INSERTED THE PINS IN THE HANDLE DRIVER AS NORMAL. THE GREEN HANDLES WERE PLACED IN THE DESIRED POSITION HARD UP AGAINST THE ANTERIOR VERTEBRAL BODY OF L5. THE GREEN PINS WERE INSERTED DOWN THE RETRACTOR HANDLES. A LATERAL X-RAY WAS TAKEN TO SEE THE PLACEMENT OF THE PINS. IT WAS THEN NOTICED THAT ONE OF THE PINS WERE BROKEN OFF IN THE VERTEBRAL BODY. THIS PIN WAS THEN REMOVED BY SCREW REMOVAL KIT. THE ALIF CONTINUED WITHOUT ANY OTHER COMPLICATION". NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263507 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK USA, INC NG10E005

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR