BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBLOC U PLUS

    MDR report key: 7931813 · Received October 3, 2018

    Report

    Report Number
    3005670412-2018-00009
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    August 25, 2018
    Report Date
    August 25, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    FZX
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A PRIMARY GUIDE TO BE USED IN SURGERY WAS FOUND BROKEN WITH BROKEN PIECE MISSING BEFORE USE. IT IS UNKNOWN IF THE INSTRUMENT BROKE IN REPROCESSING OR NOT. AN ALTERNATE GUIDE WAS USED TO COMPLETE THE SURGERY WITHOUT INCIDENT. A PREVIOUS GUIDE WAS BROKEN AND REPORTED ON MFG REPORT # 3005670412-2018-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773687 RIBLOC U PLUS PRIMARY GUIDE, LOW PROFILE FZX ACUTE INNOVATIONS LLC RBL2320 L1705006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention