BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 3475226 · Received November 18, 2013

    Report

    Report Number
    1030489-2013-04571
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Date of Event
    October 31, 2013
    Report Date
    January 23, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2990826, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2990826, 510K # K073291 WAS CLEARED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT ONLY THE TOP ~3MM PORTION OF THE IMPLANT RETURNED FOR ANALYSIS, CONSISTENT WITH THE END OF THE INSERTER THREADED INNER ROD. FRACTURE INITIATION APPEARS TO HAVE AT APPROXIMATELY 5-6 THREADS FROM THE TOP FACE, INITIATING AT THE ROOT OF THE THREAD, AND EMANATING OUTWARD. THE ANGULATION OF THE FRACTURE RELATIVE TO THE AXIS OF THE IMPLANT, IN ADDITION TO THE SHEAR LIP ON ONE SIDE OF THE IMPLANT, IS CONSISTENT WITH BENDING STRESSES. NO DEFORMATION OF THE THREADS, OR INSERTER TANG SLOTS IS NOTED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BRITTLE OVERLOAD DUE TO BENDING STRESSES.

    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, THE IMPLANT WAS BROKEN AFTER IMPLANTATION. THE BROKEN PART WAS REMOVED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597747 CAPSTONE® SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H12E4070

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR