BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 19484581 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05243
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    January 4, 2022
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PROBABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. 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.

    Description of Event or Problem · 0

    ON 01/04/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AR-9400 SBK IMPLANT SYSTEM HAD 2 FIBERTAKS PULL OUT. THIS OCCURRED DURING AN UNKNOWN PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 01/05/2022: THE PROCEDURE BEING PERFORMED WAS AN ECLIPSE. THE DEVICE PULLED OUT OF THE BONE. THE DEVICE DID NOT BREAK INSIDE OF THE PATIENT. THE BONE QUALITY OF THE PATIENT WAS POOR TO AVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422853 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 14562787 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown