BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE INSTRUMENT

    MDR report key: 20246933 · Received September 17, 2024

    Report

    Report Number
    MW5159686
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    September 12, 2024
    Report Date
    September 13, 2024
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SCREW CAME OUT OF 3MM KERRISON WHILE IN USE. ALL PIECES RETRIEVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295345 LIFE INSTRUMENT RONGUER HTX LIFE INSTRUMENT CORP. 830-0803-0

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention