BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24482570 · Received March 2, 2026

    Report

    Report Number
    1220246-2026-01108
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    July 1, 2018
    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 2018 BY EUROPEAN SOCIETY OF SPORTS TRAUMATOLOGY, KNEE SURGERY, ARTHROSCOPY TITLED ¿COMBINED ARTHROSCOPICALLY ASSISTED CORACO AND ACROMIOCLAVICULAR STABILIZATION OF ACUTE HIGH-GRADE ACROMIOCLAVICULAR JOINT SEPARATIONS¿. THE STUDY REVIEWED FIFTY-NINE (59) PATIENTS WHO UNDERWENT ARTHROSCOPICALLY ASSISTED CORACO- AND ACROMIOCLAVICULAR STABILIZATION FOR AC JOINT INJURY USING ARTHREX FIBERTAPE TO ADDRESS SOFT TISSUE APPROXIMATION AND/OR LIGATION. DURING THE TWENTY-SIX (26) MONTH FOLLOW-UP PERIOD FOUR (4) PATIENTS EXPERIENCED REVISION SURGERY. REF: HANN, C., KRAUS, N., MINKUS, M., MAZIAK, N. & SCHEIBEL, M. COMBINED ARTHROSCOPICALLY ASSISTED CORACO- AND ACROMIOCLAVICULAR STABILIZATION OF ACUTE HIGH-GRADE ACROMIOCLAVICULAR JOINT SEPARATIONS. KNEE SURG SPORTS TRAUMATOL ARTHROSC 26, 212-220, DOI:10.1007/S00167-017-4643-2 (2018).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539949 UNK POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other