BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 25222639 · Received May 19, 2026

    Report

    Report Number
    3006742481-2026-00006
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    December 31, 2025
    Report Date
    May 19, 2026
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    MBI
    PMA / PMN Number
    K240835
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE SUTURE-BUTTON REPAIR SYSTEM STATES THE FOLLOWING: "THE PATIENT MUST BE CAUTIONED, PREFERABLY IN WRITING, ABOUT THE USE, LIMITATIONS, AND POTENTIAL ADVERSE EFFECTS OF THIS DEVICE INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT OF LOOSE FIXATION AND/OR LOOSENING, STRESS, EXCESSIVE ACTIVITY, OR WEIGHT BEARING OR LOAD BEARING, AND THE POSSIBILITY OF NERVE OR SOFT TISSUE DAMAGE RELATED TO EITHER SURGICAL TRAUMA OR THE PRESENCE OF THE DEVICE." "POSTOPERATIVELY AND UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE AND BONE." THE SUTURE LIKELY RUPTURED AS A RESULT OF A NEW ADVERSE EVENT, PRIOR TO SIGNIFICANT HEALING OF THE SOFT TISSUE. THE SURGEON DID NOT ATTRIBUTE THE FAILURE TO THE DEVICE.

    Description of Event or Problem · 0

    THE PATIENT'S DISTAL BICEPS REPAIR SUTURE RUPTURED WHILE FALLING DIRECTLY ON THE AFFECTED AREA ONE WEEK AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498943 SKELETAL DYNAMICS INC. SUTURE-BUTTON REPAIR SYSTEM MBI SKELETAL DYNAMICS INC. EL2401001

    Patients

    Seq Age Sex Outcome Treatment
    1