BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 2413757 · Received January 12, 2012

    Report

    Report Number
    1030489-2012-00041
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    January 11, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT AFTER THE OBSERVATION OF THE PARTS RETURNED 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

    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 INTRADISCAL STABILIZATION PROCEDURE. DURING THE PROCEDURE, THE SURGEON INSERTED THE PINS INTO THE VERTEBRAL BODY AS USUAL, HOWEVER WHEN THE SURGEON REMOVED THE PINS HE DISCOVERED THAT THEY HAD BROKEN AND THE TIPS REAMINED IN THE VERTEBRAL BODY AND WERE NOT ABLE TO BE REMOVED. THE POINT OF BREAKAGE IS BETWEEN THE VALVE AND THE BONE. 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 CB05G007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other