BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 1996644 · Received February 18, 2011

    Report

    Report Number
    1030489-2011-00166
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MDT SWINNEA DC
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED RIGHT SIDE COVERPLATE ATTACHMENT IS LEG BROKEN ON THE INSIDE, CONSISTENT WITH LATERAL OVER-EXTENSION OF LEG DURING ATTEMPTED INSERTION OF COVERPLATE. MICROSCOPIC EXAMINATION OF FRACTURE REVEALS A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. PER EVENT INFORMATION, THE ARM BENT UNDER ITSELF DURING ATTEMPTED INSERTION, AND BROKE WHEN ATTEMPTING TO STRAIGHTEN IT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE DUE TO INAPPROPRIATE SURGICAL TECHNIQUE, RESULTING IN THE FOREGOING EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7967216, 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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVER PLATE BROKE DURING INSERTION. A NEW COVER PLATE WAS USED. ALTHOUGH THIS EVENT OCCURRED DURING SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SPINAL SYSTEM MAX MDT SWINNEA DC 202603264

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR