BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 6776322 · Received August 9, 2017

    Report

    Report Number
    1030489-2017-01885
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 15, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    OVD
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR. TWO LOTS OF THE SUSPECT DEVICE WAS IDENTIFIED, HOWEVER IT IS UNKNOWN WHICH ONE IS THE COMPLAINT PRODUCT. THE LOTS THAT WERE USED LOT 203784839; LOT 204283935. THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH PRODUCT ID: 7969814, (B)(4) AND 510K NUMBER K091813 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING DEVICES WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: "BY REPORT, L4-5 SOVEREIGN INTERBODY GRAFT SPLIT DURING SCREW INSERTION. A SINGLE X-RAY IS PROVIDED, I DO NOT SEE THE HARDWARE FAILURE IN THIS IMAGE. GRAFT PLACEMENT USED SIZE APPEARS APPROPRIATE." IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, WHEN SCREWING THE LAST OF THREE SCREWS, THE CAGE WAS SPLIT. THE CAGE COULD NOT BE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561349 SOVEREIGN SPINAL SYSTEM OVD MSD DEGGENDORF MFG NA 208847508

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SCREWS