BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24482711 · Received March 2, 2026

    Report

    Report Number
    1220246-2026-01103
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    July 1, 2021
    Report Date
    March 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    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 03-FEB-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2021 BY ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY TITLED ¿HIGH EARLY-ONSET ACROMIOCLAVICULAR SECONDARY PATHOLOGIES AFTER ACUTE ARTHROSCOPIC JOINT REDUCTION: A COHORT STUDY¿. THE STUDY REVIEWED ONE HUNDRED AND TWO (102) PATIENTS WHO UNDERWENT ACUTE AC JOINT REDUCTION AND FIXATION USING ARTHREX FIBERTAPE TO ADDRESS SOFT TISSUE APPROXIMATION AND/OR LIGATION. DURING THE TWENTY-ONE (21) WEEK FOLLOW-UP PERIOD SEVEN (7) PATIENTS REQUIRED REVISION SURGERY. REF: MARSALLI, M., BISTOLFI, G., MORÁN, N., CARTAYA, M. & URQUIDI, C. HIGH EARLY-ONSET ACROMIOCLAVICULAR SECONDARY PATHOLOGIES AFTER ACUTE ARTHROSCOPIC JOINT REDUCTION: A COHORT STUDY. ARCH ORTHOP TRAUMA SURG 142, 1623-1631, DOI:10.1007/S00402-021-04123-4 (2022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125462 UNK POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other