BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 4271636 · Received November 22, 2014

    Report

    Report Number
    1030489-2014-04532
    Event Type
    Injury
    Date Received
    November 22, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    K091813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 # 7968210, 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 # 7968210, 510K # K091813 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ALIF PROCEDURE. DURING IMPLANTATION, IT WAS REPORTED THAT THE CAGE WAS BROKEN. "A POSTERIOR PIECE OF THE CAGE AND "A NOTER" REMAINED INSIDE THE PATIENT. LEVELS IMPLANTED WERE L5-S1."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758896 SOVEREIGN SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 203371459

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR