BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1649804 · Received April 1, 2010

    Report

    Report Number
    1030489-2010-00452
    Event Type
    Injury
    Date Received
    April 1, 2010
    Report Date
    March 2, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 #855-012, 510K # K981676 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 PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION. THE ROD BROKE AT UNKNOWN TIME POST OP. THE SECONDARY SURGERY WAS PERFORMED APPROXIMATELY 20 MONTHS POST OP TO REMOVE ALL IMPLANTS. THE PATIENT REPORTEDLY WAS DOING WELL POST THE SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM ROD KWP WARSAW ORTHOPEDIC INC NA W05C0789

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention