BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24460925 · Received February 26, 2026

    Report

    Report Number
    1220246-2026-00984
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    July 1, 2023
    Report Date
    February 26, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 28-JAN-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2023 BY THE JOURNAL OF ORTHOPEDIC SCIENCE TITLED ¿STEPWISE DECISION MAKING FOR CFL REPAIR IN ADDITION TO ARTHROSCOPIC ATFL REPAIR YIELDS GOOD CLINICAL OUTCOMES IN CHRONIC LATERAL ANKLE INSTABILITY REGARDLESS OF THE REMNANT QUALITY¿. THE STUDY REVIEWED SEVENTEEN (17) PATIENTS WHO UNDERWENT FOOT AND ANKLE PROCEDURES USING ARTHREX FIBERTAK DEVICES. ONE (1) PATIENT WAS DOCUMENTED TO HAVE HAD ANKLE INSTABILITY RESULTING FROM RECURRENCE (LAPIDUS ARTHRODESIS) DURING THE TWENTY-ONE (21) MONTH FOLLOW-UP PERIOD. REF: NAKASA, T., ET AL. (2023). "STEPWISE DECISION MAKING FOR CFL REPAIR IN ADDITION TO ARTHROSCOPIC ATFL REPAIR YIELDS GOOD CLINICAL OUTCOMES IN CHRONIC LATERAL ANKLE INSTABILITY REGARDLESS OF THE REMNANT QUALITY." J ORTHOP SCI 28(5): 1087-1092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514050 UNK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other