BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 2217224 · Received August 19, 2011

    Report

    Report Number
    1030489-2011-01065
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7966025, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7966025, 510K # K091813 WAS CLEARED IN THE UNITED STATES. A REVIEW OF INTRAOPERATIVE RADIOGRAPHIC IMAGES SHOW SOVEREIGN POSITIONED AT L5-S1 FOR AN UNSTABLE SPONDYLOLISTHESIS. INITIAL FILMS SHOW NEAR REDUCTION OF SPONDYLOLISTHESIS WITH IMPLANT POSTERIORLY POSITIONED, BUT WITH MINIMAL SCREW ENDPLATE PURCHASE. POST-OP X-RAY SHOWS COMPLETE SPITTING OF DEVICE ANTERIORLY WITH COLLAPSE OF L5 DISC SPACE, RECURRENCE OF SLIP AND LOSS OF PURCHASE OF ALL SCREWS. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE RE PORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE TO TREAT MOBILE SPONDYLOLISTHESIS WITH AN INTERBODY DEVICE AT L5-S1. REPORTEDLY, THE SCREW AT S1 WAS IMPLANTED INTO AN OSTEOPHYTE. 3 DAYS POST-OPERATIVELY THE OSTEOPHYTE BROKE AWAY CAUSING THE SCREW TO BECOME UNSTABLE AND DISLODGE. 10 DAYS POST-OPERATIVELY THE PATIENT UNDERWENT A POSTERIOR REVISION PROCEDURE, REPLACING THE INTERBODY DEVICE AND ADDING SUPPLEMENTAL POSTERIOR FIXATION. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SPINAL SYSTEM MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention SOVEREIGN SPINAL SYSTEM