BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2033289 · Received March 30, 2011

    Report

    Report Number
    1030489-2011-00353
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K052054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LATERAL FUSION SURGICAL PROCEDURE AT L2-S1. IT WAS REPORTED THAT SOMETIME POST OP THE PATIENT COMPLAINED OF PAIN. DURING AN X-RAY, IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN AT S1. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO REPLACEMENT WAS NEEDED BECAUSE FUSION HAD OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONNECTORS, RODS