BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 2616268 · Received June 14, 2012

    Report

    Report Number
    1030489-2012-00974
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 25, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO DEFECT HAS BEEN IDENTIFIED THAT WOULD HAVE BEEN RESPONSIBLE FOR THE FAILURE OF THE PART. THE FAILURE IS CONSISTENT WITH BREAKAGE DUE TO OVER-LOADING IN TORSION AND BENDING.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE, DURING THE PROCEDURE, THE SURGEON INSERTED THE PINS INTO THE VERTEBRAL BODY AS USUAL. UPON REMOVING THE PINS, IT WAS DISCOVERED THAT THE PIN WAS BROKEN AND THE TIP REMAINED IN THE VERTEBRAL BODY OF THE PATIENT. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING MA07G148

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR