BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH

    MDR report key: 13266218 · Received January 17, 2022

    Report

    Report Number
    1030489-2022-00045
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    December 21, 2021
    Report Date
    January 17, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. PRODUCT: G828H083 IS NOT MARKETED IN THE US, BUT IS SIMILAR TO OTHER MARKETED DEVICES. THUS, IT IS REPORTABLE FOR MALFUNCTION, NOT SERIOUS INJURY, ALTHOUGH SURGICAL INTERVENTION DID TAKE PLACE. THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 828-083, 510K# K880215 AND UDI (B)(4) IS APPROVED FOR SALE IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PJK INVOLVED IN THE POSTERIOR THORACOLUMBAR VERTEBRAE FUSION PROCEDURE. LEVELS IMPLANTED- T6-S2. IT WAS REPORTED THAT DURING USE, ROD BROKE. REVISION SURGERY WAS PLANNED TO EXPLANT THE PRODUCT ON (B)(6) 2021. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. REPORTED EVENT IS REVISION SURGERY. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2016. PROCEDURE WAS L2-ILIAC FUSION. MDT PRODUCTS USED IN INITIAL SURGERY WAS TSRH RP, LEGACY ILIAC. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT PATIENT SYMPTOMS ARE UNKNOWN. PRODUCT WAS DISCARDED BY THE CUSTOMER AFTER EXPLANTING IT FROM THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808520 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G828H083 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention