BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 7040786 · Received November 17, 2017

    Report

    Report Number
    1030489-2017-02352
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 17, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHETHER BOTH THE REPORTED DEVICES LED TO THE EVENT OR NOT, WE ARE FILLING THIS REPORT FOR NOTIFICATION PURPOSES. UNKNOWN DEVICE WITH QUANTITY 2 WERE INVOLVED IN THE EVENT. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT L2-5 DUE TO LUMBAR CANAL STENOSIS. REPORTEDLY, POST-OP, THE PATIENT DEVELOPED PROXIMAL JUNCTIONAL FAILURE (PJF). IN REVISION SURGERY PEDICLE SUBTRACTION OSTEOTOMY (PSO) WAS PERFORMED AT L2 DUE TO PJF. BOTH THE IMPLANTS WERE EXPLANTED DURING THE REVISION SURGERY. POST REVISION SURGERY PATIENT ISSUE RESOLVED AND NO MALFUNCTION WAS REPORTED FOR THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821550 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention