BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 7962359 · Received October 12, 2018

    Report

    Report Number
    1030489-2018-01353
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    September 13, 2018
    Report Date
    December 7, 2018
    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 FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 828-090, 510K# K964275 AND UDI (B)(4) IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: IMAGE REVIEW: X-RAY IMAGE AP IS LONG SEGMENT THORACOLUMBAR FUSION. INTERBODY CAGE IS PRESENT AT L2 AND PRESUMABLY A LARGE AMOUNT OF BONE GRAFT MATERIAL. THE RODS AT L2 ARE FRACTURED BILATERALLY. UNABLE TO ASSESS SAGITTAL FRACTURE OR FUSION STATE ON PROVIDED IMAGING. 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 THORACOLUMBAR VERTEBRA POSTERIOR FUSION AT TH4-S2AI . POST-OP, ROD BREAKAGE DUE TO DYSRAPHISM OCCURRED BETWEEN L5/S AND BETWEEN L2/L4 ON THE RIGHT SIDE. THE ROD BETWEEN L2/L4 ON THE LEFT SIDE ALSO BROKE. IN THE REVISION SURGERY, BOTH SIDES WERE CONNECTED USING MRC AND ROD WAS ADDED. ON THE RIGHT SIDE WHERE BREAKAGE OCCURRED TO TWO PARTS, THE BROKEN PART WAS REMOVED AND DISCARDED. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803563 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other