BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24458637 · Received February 26, 2026

    Report

    Report Number
    1220246-2026-00965
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    July 1, 2025
    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 2025 BY THE JOURNAL EXPLANTED ORTHOPEDICS TITLED ¿COMPARATIVE EFFECTIVENESS OF COMBINED ATFL AND CFL REPAIR VERSUS ATFL-ONLY REPAIR FOR SEVERE CHRONIC LATERAL ANKLE INSTABILITY¿. THE STUDY REVIEWED FORTY (41) PATIENTS WHO UNDERWENT FOOT AND ANKLE PROCEDURES USING ARTHREX FIBERTAK DEVICES. EIGHT (8) PATIENTS WERE DOCUMENTED TO HAVE HAD ANKLE INSTABILITY RESULTING IN SEVEN (7) PATIENTS EXPERIENCING RECURRENT ANKLE INSTABILITY DURING THE SIXTEEN (16) MONTH FOLLOW-UP PERIOD. REF: YOSHIMOTO, K., ET AL. (2025). "COMPARATIVE EFFECTIVENESS OF COMBINED ATFL AND CFL REPAIR VERSUS ATFL-ONLY REPAIR FOR SEVERE CHRONIC LATERAL ANKLE INSTABILITY." J EXP ORTHOP 12(3): E70345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514452 UNK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other