BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24457494 · Received February 26, 2026

    Report

    Report Number
    1220246-2026-00947
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    July 1, 2024
    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 2024 BY THE ARTHROSCOPY JOURNAL TITLED ¿THE ARTHROSCOPIC SUBSCAPULAR SLING PROCEDURE RESULTS IN LOW RECURRENT ANTERIOR SHOULDER INSTABILITY AT 24 MONTHS OF FOLLOW-UP¿. THE STUDY REVIEWED FIFTEEN (15) PATIENTS WHO UNDERWENT SHOULDER PROCEDURES USING ARTHREX FIBERTAK DEVICES. TWO (2) PATIENTS WERE DOCUMENTED TO HAVE HAD GLENOHUMERAL INSTABILITY RESULTING IN A CYST FORMATION DURING THE TWENTY-FOUR (24) MONTH FOLLOW-UP PERIOD. REF: KLUNGSØYR, J. A., ET AL. (2024). "THE ARTHROSCOPIC SUBSCAPULAR SLING PROCEDURE RESULTS IN LOW RECURRENT ANTERIOR SHOULDER INSTABILITY AT 24 MONTHS OF FOLLOW-UP." ARTHROSCOPY 40(10): 2543-2552.E2541.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515753 UNK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other