BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBLOC U PLUS CHEST WALL PLATING SYSTEM ACUTE INNOVATIONS

    MDR report key: 17836665 · Received September 27, 2023

    Report

    Report Number
    MW5146273
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ACUMED, LLC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDE PIECE WAS FOUND TO BE BROKEN AFTER SUBSEQUENT XRAY WAS TAKEN WITH MD NOTICING PIECE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/19/2023 FOR REPORT MW5146237 TO CHANGE THE MANUFACTURER TO ACUMED LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003579 RIBLOC U PLUS CHEST WALL PLATING SYSTEM ACUTE INNOVATIONS PLATE, FIXATION, BONE HRS ACUMED, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown