BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 3105948 · Received May 10, 2013

    Report

    Report Number
    1030489-2013-01652
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K091813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7967214, 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 # 7967214, 510K # K091813 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DISCECTOMY WITH CAGE IMPLANTATION AT THE L5/S1. "DURING IMPLANTATION, THE CAGE CRACKED UPON FINAL TIGHTENING. CRACK WAS RIGHT UNDER THE LEFT SIDE INFERIOR SCREW HOLE AND ADVANCED DOWN TO THE INFERIOR ENDPLATE OF THE CAGE. THE SURGEON DECIDED TO LEAVE THE IMPLANT IN AND ATTACHED THE COVER PLATE AS NORMAL WITHOUT ANY PROBLEMS." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208317 SOVEREIGN SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH 204284380

    Patients

    Seq Age Sex Outcome Treatment
    1