BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 4358581 · Received December 23, 2014

    Report

    Report Number
    1030489-2014-04842
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 24, 2014
    Report Date
    November 26, 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): 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ALIF PROCEDURE AT L5. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CAGE BROKE AND SOME FRAGMENTS REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846505 SOVEREIGN SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 207404314

    Patients

    Seq Age Sex Outcome Treatment
    1