BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBLOC

    MDR report key: 15300798 · Received August 26, 2022

    Report

    Report Number
    15300798
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 15, 2022
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE LOW-PROFILE PRIMARY GUIDE, USED BY THE ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM, (REF# RBL2320) BROKE INTO TWO PIECES IN THE PATIENT WHILE IN SURGERY, DURING THE COMPRESSING FOR THE RIB PLATE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436327 RIBLOC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUTE INNOVATIONS LLC RBL2320

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Unknown