BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 8854336 · Received August 2, 2019

    Report

    Report Number
    1030489-2019-00855
    Event Type
    Injury
    Date Received
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR MARKET IN THE US. HOWEVER A LIKE DEVICE WITH PART# 8293420, 510K# K031967 IS MARKETED IN THE US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3-L5 DUE TO STENOSIS. ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD RADICULOPATHY AT L5 AND ADJACENT SEGMENT DISEASE. HENCE, ON AN UNKNOWN DATE, THE SURGEON PERFORMED EXTENSION OF FUSION (POSTERIOR LUMBAR INTERBODY FUSION) AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651301 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0721937W

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other