BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALIGN

    MDR report key: 22616666 · Received July 25, 2025

    Report

    Report Number
    1421101-2025-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 22, 2025
    Manufacturer
    AVALIGN TECHNOLOGIES INC
    Product Code
    GEN
    UDI-DI
    00190776060923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON 30JUN2025, QUALITY RECEIVED A CUSTOMER COMPLAINT NOTIFICATION. THE CUSTOMER STATED: "WE ARE HAVING SOME ISSUES WITH THIS SPECIFIC INSTRUMENT. WE HAVE BROKEN PROBABLY 4 OF THEM SO FAR, WHEN PUT UNDER EVEN SLIGHT PRESSURE. ONE OF THE ENDS COMPLETELY SNAPPED OFF DURING A SURGERY TODAY WHILE TRYING TO GRAB HOLD OF THE FEMORAL NECK AS YOU CAN SEE IN THE PICTURE I'VE ATTACHED. NO PATIENT INJURIES WERE HAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211218 AVALIGN LEWIN BONE FORCEPS GEN AVALIGN TECHNOLOGIES INC VM38-1931 050124 00190776060923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other