BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1578852 · Received December 31, 2009

    Report

    Report Number
    1030489-2009-01260
    Event Type
    Malfunction
    Date Received
    December 31, 2009
    Date of Event
    December 8, 2009
    Report Date
    December 3, 2009
    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): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE SUSPECT DEVICES IN USE ARE LOT# W06G1984 AND #W07A4581. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG# 8699045, 510K# K981676 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT W06G1984 IS 09/19/2006; MANUFACTURE DATE FOR LOT W07A4581 IS 02/22/2007. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT THE FOURTH SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION FROM L2 TO T9. CROSSLINK WAS ALSO IMPLANTED. IT WAS RECENTLY REPORTED THAT FUSION FAILED AND THE ROD BROKE CLOSE TO THE IMPLANTED CROSSLINK. REVISION SURGERY IS REPORTEDLY PLANNED BUT IS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM ROD NKB WARSAW ORTHOPEDIC INC. NA W06G1984

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention