BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 3229740 · Received July 16, 2013

    Report

    Report Number
    1030489-2013-03044
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 1, 2013
    Report Date
    November 19, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT ONLY THE TOP ~3MM PORTION OF THE IMPLANT RETURNED FOR ANALYSIS. FRACTURE INITIATION APPEARS TO HAVE AT APPROXIMATELY 5-6 THREADS FROM THE TOP FACE, INITIATING AT THE ROOT OF THE THREADED HOLE, AND EMANATED OUTWARD. THE THREADS APPEAR TO HAVE BEEN STRIPPED. NO DEFORMATION OF THE THREADED HOLE IS NOTED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BRITTLE OVERLOAD DUE TO EXCESSIVE FORCE DURING IMPLANTATION.

    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 FROM L4-S1. DURING CAGE IMPLANTATION, IT WAS NOTED THAT A SMALL PART OF THE CAGE BROKE. WHEN THE DOCTOR TRIED HAMMERING A SECOND CAGE, IT BROKE AS WELL. BOTH BROKEN CAGES WERE REMOVED COMPLETELY AND A NEW IMPLANT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329561 CAPSTONE® SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG H13C0945

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR