BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 10222747 · Received July 2, 2020

    Report

    Report Number
    1030489-2020-00774
    Event Type
    Injury
    Date Received
    July 2, 2020
    Report Date
    July 2, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWB
    PMA / PMN Number
    K031967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A POST-OP EVENT FOR A PATIENT DIAGNOSED WITH STENOSIS AT L3/5, WHO UNDERWENT PLF AT L1/2/3. IT WAS REPORTED THAT VERTEBRAL BODY OF L2 HAD COLLAPSED POST-OP AND REVISION SURGERY OF PLF WAS PERFORMED AT L1/3. NO DEVICE MALFUNCTION WAS ALLEGED. THE PRODUCT WAS EXPLANTED, AND IT WAS REPLACED WITH MEDTRONIC PRODUCT. HEALTH INJURY WAS REPORTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687546 TSRH PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL KWB WARSAW ORTHOPEDICS G8292035 0015443W

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other