BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH® SPINAL SYSTEM

    MDR report key: 5768581 · Received July 5, 2016

    Report

    Report Number
    1030489-2016-01990
    Event Type
    Injury
    Date Received
    July 5, 2016
    Report Date
    June 6, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED TO BE MARKETED IN US. BUT A SIMILAR PRODUCT ((B)(4)), 510K# K022778 IS APPROVED TO BE MARKETED IN US. PATIENT CODES (PSEUDOARTHROSIS, INTERVENTION REQUIRED). 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT'S SPINAL SLIPPAGE AGGRAVATED DUE TO A LOOSENING L4 SCREW AND ALSO THE CAGE BACKED OUT. PSEUDOARTHROSIS(NON UNION) WAS SUSPECTED. THE PATIENT DID NOT ACHIEVE SUCCESSFUL BONE UNION. REVISION SURGERY WOULD BE PERFORMED TO REPLACE THE SCREW AND THE CAGE. LOW BACK PAIN WAS RECURRED DUE TO PSEUDOARTHROSIS. THE PATIENT RE-HOSPITALIZED DUE TO REVISION SURGERY. REVISION SURGERY WAS SCHEDULED ON (B)(6) 2016. THE PATIENT UNDERWENT A FENESTRATION FOR LSCS AT L4/5 IN INITIAL SURGERY. AFTER THE SURGERY, THE PATIENT UNDERWENT TLIF SURGERY ON UNKNOWN DATE. POSTOPERATIVELY SOLID BONE WAS NOT ACHIEVED. TWO L4 SCREWS (6.50 X 40) WERE FOUND LOOSE. L4 CAGE APPEARED TO MIGRATE POSTERIOR DUE TO SPONDYLOLISTHESIS. ANOTHER REVISION SURGERY WAS SCHEDULED. THE PRODUCTS CAME IN THE CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423270 TSRH® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R