BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED GUIDE WIRE

    MDR report key: 15958813 · Received December 9, 2022

    Report

    Report Number
    MW5113713
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ADVANCED RESEARCH MEDICAL LLC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    K-WIRE BROKE OFF WHEN TRYING TO REMOVE FROM BONE. PROVIDER CHOOSE TO LEAVE IN BONE, WOULD CAUSE MORE HARM TO TRY TO REMOVE THAN LEAVING IN PLACE. PROVIDER STATES HE'S BROUGHT THIS ISSUE TO THE MANUFACTURE OF THE PRODUCT WITH NO RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181616 THREADED GUIDE WIRE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL LLC 080422

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Other