BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAT DECUBITUS SHOULDR TRACN DEV

    MDR report key: 19323330 · Received May 15, 2024

    Report

    Report Number
    1220246-2024-03342
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    July 15, 2021
    Report Date
    May 15, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KQZ
    UDI-DI
    00888867020368
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. SUPPLIER EVALUATION IDENTIFIED SEVERAL DAMAGED COMPONENTS DUE TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CORD ON THE AR-1630 IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547135 LAT DECUBITUS SHOULDR TRACN DEV TRACTION APPARATUS KQZ ARTHREX, INC. LAT DECUBITUS SHOULDR TRACN DEV 00888867020368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown