BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENOTAC SOFT TISSUE FIXATION SYSTEM

    MDR report key: 16570255 · Received March 18, 2023

    Report

    Report Number
    3008650117-2023-00057
    Event Type
    Injury
    Date Received
    March 18, 2023
    Date of Event
    December 21, 2022
    Report Date
    March 17, 2023
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    4247: THIS COMPLAINT WAS NOT ESCALATED TO ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 0

    MATING INTERACTION FAILURE WAS REPORTED DURING PATIENT USE; THE MALE IMPLANT BACKED OUT OF THE FEMALE IMPLANT. THE IMPLANTS WERE REMOVED. THE PATIENT IS SAID TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998606 TENOTAC SOFT TISSUE FIXATION SYSTEM TENOTAC 2.0 FEMALE IMPLANT HWC PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention