BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 5255903 · Received November 30, 2015

    Report

    Report Number
    1030489-2015-03211
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    October 30, 2015
    Report Date
    January 12, 2016
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    OVD
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL INSPECTION IDENTIFIES CRACKING AT THE RIGHT SIDE SCREW BOSS HOLE, AT THE THINNEST CROSS SECTION. THE CRACK APPEARS TO HAVE INITIATED AT THE INTERSECTION OF THE OUTER WALL AND THE SCREW BOSS HOLE WHERE THE SHARP CORNER COULD ACT AS A STRESS RISER. OPTICAL EXAMINATION IDENTIFIED CIRCULAR PLASTIC DEFORMATIONS ON THE INTERIOR OF THE SCREW BOSS HOLE, CONSISTENT WITH OVER INSERTION OR MISALIGNMENT OF THE BONE SCREWS, WHICH COULD RESDEFORMATIOULT IN OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH PRODUCT ID: 7969210 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT L5/S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF). INTRA-OP, CAGE WAS SIZED WITH TRIALS. SURGEON OPTED FOR 10MM HEIGHT LARGE FOOTPRINT CAGE WHICH WAS INSERTED AS PER SURGICAL TECHNIQUE. MIDDLE SCREW INSERTED AS NORMAL WITH CURVED AWL AND HAMMER. LATERAL SCREW - CURVED AWL WAS INSERTED WITH INTRODUCER. AWL HIT WITH HAMMER BECAUSE OF HIGH DENSITY BONE. ONCE AWL REMOVED, IT WAS NOTICED THAT THE CAGE WAS CRACKED. IMPLANT WAS REMOVED AND REPLACED WITHOUT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784945 SOVEREIGN SPINAL SYSTEM OVD MSD DEGGENDORF MFG NA 203152573

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR