BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 6672496 · Received June 27, 2017

    Report

    Report Number
    1030489-2017-01637
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 1, 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 PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 828-083, 510K# K880215 AND (B)(4) IS APPROVED FOR SALE IN US. (REVISION SURGERY) NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LEVELS: TH8-IL IT WAS REPORTED THAT PATIENT WITH KYPHOSCOLIOSIS UNDERWENT PEDICLE SUBTRACTION OSTEOTOMY. POST-OP,ROD WAS BROKEN. ON (B)(6) 2017 ROD REPLACEMENT (REVISION SURGERY) WAS PERFORMED WITH 4 RODS DUE TO ROD BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452849 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention