BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2920045 · Received January 17, 2013

    Report

    Report Number
    1030489-2013-00157
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 20, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGERY. IT WAS REPORTED THAT THE SCREW HAD LOOSENED. A REVISION SURGERY WAS PERFORMED SOMETIME POST-OP AND THE HARDWARE WAS REMOVED AND REPLACED WITH A DIFFERENT SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25558 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention