BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24497271 · Received March 3, 2026

    Report

    Report Number
    1220246-2026-01167
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    July 1, 2023
    Report Date
    March 3, 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 2023 BY THE ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY TITLED ¿COMPARISONS BETWEEN TREATMENT OF ISOLATED POSTEROSUPERIOR PARALABRAL CYSTS AND SIMULTANEOUS TREATMENT OF CYSTS COMBINED WITH ASSOCIATED SHOULDER PATHOLOGIES: ARTHROSCOPIC TREATMENT OF POSTEROSUPERIOR PARALABRAL CYSTS¿. THE STUDY REVIEWED SEVENTY (70) PATIENTS WHO UNDERWENT ARTHROSCOPIC TREATMENT OF POSTEROSUPERIOR PARALABRAL CYSTS ± ASSOCIATED SHOULDER PATHOLOGIES USING ARTHREX FIBERWIRE TO ADDRESS SOFT TISSUE APPROXIMATION AND/OR LIGATION. DURING THE EIGHTEEN (18) MONTH FOLLOW-UP PERIOD, TWO (2) PATIENTS EXPERIENCED RESIDUAL CYSTS, AND THREE (3) PATIENTS FAILED TO RECOVER RANGE OF MOTION. REF: JI, X. ET AL. COMPARISONS BETWEEN TREATMENT OF ISOLATED POSTEROSUPERIOR PARALABRAL CYSTS AND SIMULTANEOUS TREATMENT OF CYSTS COMBINED WITH ASSOCIATED SHOULDER PATHOLOGIES: ARTHROSCOPIC TREATMENT OF POSTEROSUPERIOR PARALABRAL CYSTS.ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2023) 143:665¿675.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410756 UNK POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other