BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN¿ SPINAL SYSTEM

    MDR report key: 2834135 · Received November 15, 2012

    Report

    Report Number
    1030489-2012-02207
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 8, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K091813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT BASED ON THE RETURNED IMPLANTS AND IMAGES, THE ORIGIN OF THE SCREW PULL-OUT CANNOT BE IDENTIFIED. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY RECEIVED SHOWS SINGLE LATERAL VIEW OF LUMBAR SPINE. NOTED ARE BILATERAL HIP REPLACEMENTS, PEDICLE SCREWS AND SEXTANT RODS AT L4 AND L5, AUGMENTED INTERBODY DEVICE AT L4-5 AND ANTERIOR PYRAMID PLATE WITH CONTRAST AUGMENTED SCREWS AT L4 AND L5. SOVEREIGN PRESENT AT L5/S1 WITH S1 SCREW APPROXIMATELY 75% BACKED OUT.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7969212, 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 # 7969212, 510K # K091813 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS DISCOVERED THAT A SCREW HAD BACKED OUT OF THE CAGE. A REVISION WAS DONE TO REMOVE THE MIGRATED SCREW. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA 205392799

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR