BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1594808 · Received February 3, 2010

    Report

    Report Number
    1030489-2010-00132
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Report Date
    January 5, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8292037, 510K # K031967 WAS CLEARED IN THE UNITED STATES. IMPLANTS REMAIN IMPLANTED. THE INTRAOPERATIVELY X-RAYS SHOW THAT COMPLEX CONSTRUCT AT L1-K2-L3-L5-TRAN-SACRAL. POST-OP FILMS SHOW DISASSOCIATION OF LEFT TRANS-SACRAL SCREW. THE FILMS CANNOT DOCUMENT DYSFUNCTION ON THE RIGHT SIDE. ROD MAY HAVE BEEN TOO SHORT ON THE LEFT WHICH COULD HAVE LEAD TO LOOSENING AND DISASSOCIATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD UNDERGONE A PROCEDURE AT L2-ILIAC USING POSTERIOR FIXATION. IT WAS REPORTED THAT ONE T-BOLT WAS LOOSENING AT ILIAC. NO REVISION SURGERY IS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM T-BOLT NKB WARSAW ORTHOPEDIC INC. NA 0054130W

    Patients

    Seq Age Sex Outcome Treatment
    1