BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 1781134 · Received July 28, 2010

    Report

    Report Number
    1030489-2010-00975
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K091813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUBMITTED PICTURE APPEARS TO SHOW A VERTICAL CRACK ON THE LEFT SIDE OF THE IMPLANT, ABOVE THE SCREW BOSS AREA. THE LOCATION AND TIMING OF THE CRACK DEVELOPMENT (DURING INSERTION OF THE SCREW), SUGGEST OVERTIGHTENING AS A POSSIBLE MECHANISM OF FAILURE. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING THE FIXATION SCREW ON THE SPACER AT L5-S1, A CRACK DEVELOPED IN THE SPACER AT ONE OF THE LATERAL SCREW HOLES. THE SPACER WAS LEFT IMPLANTED IN THE PT. NO ADD'L COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SPINAL SYSTEM CAGE MAX SOFAMOR DANEK DEGGENDORF GMBH NA 202764738

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT:| FIXATION SCREW