BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 16594811 · Received March 22, 2023

    Report

    Report Number
    3006981798-2023-00013
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    January 11, 2023
    Report Date
    March 22, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087154
    PMA / PMN Number
    K203740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. THE REPORT COULD NOT BE SUBSTANTIATED AND A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR PULLED OUT FROM THE PATIENT'S BURRHOLE ALTHOUGH THE SURGEON IMPLANTED THE ANCHOR OF THIS COMPLAINT PRODUCT FOLLOWING THE NORMAL USAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828368 JUGGERKNOT SOFT ANCHOR FIXATION DEVICE MBI RIVERPOINT MEDICAL LLC CM-99115B 22080329 00810020087154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown