BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 6700035 · Received July 11, 2017

    Report

    Report Number
    1030489-2017-01721
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    June 12, 2017
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #828-090, 510K #K964275 AND UDI (B)(4) WAS CLEARED IN THE UNITED STATES. REVISION SURGERY, PSEUDOARTHROSIS, KYPHOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION AFTER LUMBAR INTERBODY FUSION AT LEVEL T9-IL DURING WHICH RODS WERE IMPLANTED. POST-OP, PROXIMAL JUNCTIONAL KYPHOSIS AND ROD BREAKAGE WERE REPORTED. THE PATIENT UNDERWENT REVISION SURGERY WHERE FIXATION RANGE WAS EXTENDED TO T7 DUE TO PROXIMAL JUNCTIONAL KYPHOSIS AND ROD WAS REPLACED DUE TO BREAKAGE. ROD WAS BROKEN DUE TO NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481211 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G828H090 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R