BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24456093 · Received February 26, 2026

    Report

    Report Number
    1220246-2026-00938
    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 ARTHROSCOPIC BONE JOINT SURGICAL JOURNAL TITLED ¿ARTHROSCOPIC STABILIZATION OF RECURRENT ANTERIOR SHOULDER INSTABILITY USING TWO ANCHORS, ONE SINGLE-LOADED PLUS ONE DOUBLE-LOADED: A PROSPECTIVE STUDY WITH MODIFIED TECHNIQUE¿. THE STUDY REVIEWED THIRTY-EIGHT (38) PATIENTS WHO UNDERWENT SHOULDER PROCEDURES USING ARTHREX FIBERTAK DEVICES. TWO (2) PATIENTS WERE DOCUMENTED TO HAVE HAD GLENOHUMERAL INSTABILITY RESULTING IN NONCLINICAL SUBLUXATION DURING THE FORTY (40) MONTH FOLLOW-UP PERIOD. REF: KOKLY, S., ET AL. (2024). "ARTHROSCOPIC STABILIZATION OF RECURRENT ANTERIOR SHOULDER INSTABILITY USING TWO ANCHORS, ONE SINGLE-LOADED PLUS ONE DOUBLE-LOADED; A PROSPECTIVE STUDY WITH MODIFIED TECHNIQUE." ARCH BONE JT SURG 12(11): 770-778.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513719 UNK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other