BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAPTIUM CONNECT

    MDR report key: 24430041 · Received February 24, 2026

    Report

    Report Number
    3021453307-2026-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 24, 2026
    Manufacturer
    TISSIUM SA
    Product Code
    SFD
    UDI-DI
    03760279380209
    PMA / PMN Number
    DEN240066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    DURING A LEFT ULNAR NERVE RECONSTRUCTION USING TWO COAPTIUM® CONNECT DEVICES, AN APPROXIMATELY 3 MM FRACTURE LINE WAS OBSERVED NEAR THE DISTAL RIDGE REGION OF THE PROXIMAL COAPTATION CHAMBER WHILE ACCOMMODATING A NERVE MEASURING APPROXIMATELY 7 MM INTO A 6 MM CHAMBER. NO FRAGMENT DETACHMENT WAS OBSERVED AND NO MATERIAL WAS RETAINED; THE DEVICE WAS NOT REPLACED. AT THE DISTAL REPAIR SITE, FIXATION TO THE POSTERIOR EPINEURIUM WAS INCOMPLETE AND TWO SUTURES WERE PLACED THROUGH THE CHAMBER AND EPINEURIUM TO COMPLETE THE REPAIR. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628456 COAPTIUM CONNECT COAPTIUM CONNECT WITH TISSIUM LIGHT SFD TISSIUM SA NCOCO6010;NCOCO5010 250700051; 250700050 03760279380209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention