BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTEN TENODESIS

    MDR report key: 24571546 · Received March 11, 2026

    Report

    Report Number
    1417592-2026-00215
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 20, 2026
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    NWN
    PMA / PMN Number
    K142230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D1, D2B, G4.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "INSERTER BECAME STUCK AND WOULD NOT RELEASE WITHOUT THE USE OF FORCE/MALLET. IMPLANT PULLED OUT AFTER MALLET WAS USED FOR REMOVAL. SURGEON HAD TO SIZE UP TO ACHIEVE ADEQUATE FIXATION AFTER ORIGINAL IMPLANT PULLED OUT." IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DIFFICULTY REMOVING INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269607 DEXTEN TENODESIS IMPLANT KIT, TENDON TRANSFER, 5.5MM NWN MEDLINE INDUSTRIES LP 18665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other