BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 3870938 · Received June 12, 2014

    Report

    Report Number
    1030489-2014-02745
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    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 ROOT OF THE THREAD, AS WELL THE MATERIAL MOVEMENT SUGGEST TORSIONAL OVERLOAD AS THE MECHANISM OF FAILURE. SHAFT DIAMETER AND MATERIAL HARDNESS PRINT SPECIFICATIONS ARE CONFIRMED TO BE WITHIN PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT "THE PIN SNAPPED WHILE THE SURGEON WAS TRYING TO REMOVE IT. SURGEON HAD TO USE SEVERAL BURRS TO RETRIEVE THE SNAPPED PORTION OUT OF THE VERTEBRAL BODY." SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PIECES REMAINING IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347450 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK USA, INC 897-406 NG13F016

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR