BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 14240071 · Received April 28, 2022

    Report

    Report Number
    3008650117-2022-00046
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 28, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CASPAR INSTRUMENT WOULD NOT ARTICULATE/OPEN FULLY DURING A SURGERY. A SECOND CASPAR INSTRUMENT AVAILABLE IN THE OPERATING ROOM WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103564 BABY GORILLA/GORILLA PLATING SYSTEM CASPAR TYPE COMPRESSION/DISTRACTION DEVICE HWN PARAGON 28, INC P99-150-0011 PB5173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown