BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 3370321 · Received September 26, 2013

    Report

    Report Number
    1030489-2013-04008
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    September 2, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 STABILITY PIN BROKE OFF INSIDE THE SACRUM. ACCORDING TO THE SURGEON, "THE FRAGMENT COULD NOT BE RETRIEVED AS IT WAS EMBEDDED IN BONE". NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487497 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING IT03G013

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR