BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XBRAID

    MDR report key: 23399056 · Received October 27, 2025

    Report

    Report Number
    3006981798-2025-00048
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 27, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    10840277401219
    PMA / PMN Number
    K153307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE.THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS, AND THE REPORT COULD NOT BE SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT 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 PULLED THROUGH TISSUE AND WASN'T USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309045 XBRAID BLUE BRAIDED UHMWPE NON-ABSORBABLE PASSING LOOP SUTURE TAPE GAT RIVERPOINT MEDICAL LLC SK-HS2130 24030104 10840277401219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown