BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410715 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00771
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    November 1, 2017
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    NDL
    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 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON NOVEMBER 2017 BY THE FOOT AND ANKLE INT JOURNAL ¿MODIFIED BROSTROM PROCEDURE USING DISTAL FIBULAR PERIOSTEAL FLAP AUGMENTATION VS ANATOMIC RECONSTRUCTION USING A FREE TENDON ALLOGRAFT IN PATIENTS WHO ARE NOT CANDIDATES FOR STANDARD REPAIR.¿ THE STUDY REVIEWED 17 PATIENTS AND IDENTIFIED BICEP ANKLE INSTABILITY RESULTING IN PARTIAL WOUND DEHISCENCE WITH BIOABSORBABLE INTERFERENCE SCREWS IN 1 PATIENT DURING THE YEAR FOLLOW-UP PERIOD. REF: CHOI HJ, KIM DW, PARK JS. MODIFIED BROSTROM PROCEDURE USING DISTAL FIBULAR PERIOSTEAL FLAP AUGMENTATION VS ANATOMIC RECONSTRUCTION USING A FREE TENDON ALLOGRAFT IN PATIENTS WHO ARE NOT CANDIDATES FOR STANDARD REPAIR. FOOT ANKLE INT. NOV 2017;38(11):1207-1214. DOI:10.1177/1071100717726303.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230239 UNK PIN, FIXATION, SMOOTH, METALLIC NDL ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown