BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1518897 · Received October 29, 2009

    Report

    Report Number
    1030489-2009-01007
    Event Type
    Injury
    Date Received
    October 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    WARSAW ORTHOPAEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 869-022, 510K # K040962 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. 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 ROD BROKE AFTER A FUSION PROCEDURE FOR A MULTIPLE FRACTURES TO PATIENT FROM T6-L5. THE PATIENT REPORTEDLY HAD GONE THROUGH MULTIPLE PROCEDURES TO FUSE THE SPINE. THE PATIENT ALSO COMPLAINED OF PAIN POST OP. THE REVISION SURGERY WAS PERFORMED ABOUT TWO MONTHS AFTER THE IMPLANTATION TO REPLACE THE BROKEN ROD AT L2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM ROD KWP WARSAW ORTHOPAEDIC INC. NA W07C4484

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention