BEUDAMED
    FDA Adverse Event Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2097696 · Received May 20, 2011

    Report

    Report Number
    1030489-2011-00610
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 # 8372545, 510K # K984522 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED FOR ANALYSIS. MACROSCOPIC EXAMINATION CONFIRMS BONE SCREWS ARE BROKEN APPROX. ~4-8 THREADS FROM THE START OF THE SCREW THREAD. MICROSCOPIC EXAMINATION OF EACH OF THE FRACTURE SURFACES REVEAL A FAIRLY FLAT FRACTURE, WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT, CONSISTENT WITH FAILURE DUE TO FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS FUSED FOUR YEARS AFTER A L4-S1 SPINAL PROCEDURE. THE REMOVAL SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE POSTERIOR FIXATION SYSTEM. IT WAS FOUND DURING THE REMOVAL PROCEDURE THAT THE PEDICLE SCREWS AT RIGHT L4 (6.5MM) AND BOTH SIDE OF S1 (RIGHT 5.5MM, LEFT 6.5MM) HAD BEEN BROKEN. REPORTEDLY THE RIGHT S1 SCREW WAS CONFIRMED BROKEN IN THREE YEARS POST IMPLANTATION. TIPS OF THOSE BROKEN SCREWS REMAINED IN THE PATIENT. NO OTHER COMPLICATION WAS REPORTED DURING AND AFTER THE REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA W05K6535

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Other ROD, SET SCREWS