BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT 250-160

    MDR report key: 6857549 · Received September 12, 2017

    Report

    Report Number
    MW5072083
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    September 2, 2017
    Report Date
    September 8, 2017
    Manufacturer
    JARIT
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SMALL PIECE OF OSTEOTOME THAT WAS USED DURING PROCEDURE BROKE OFF IN SURGICAL SITE AND WAS MISPLACED. X-RAY WAS COMPLETED AND THE PIECE WAS LOCATED, BUT UNABLE TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640219 JARIT 250-160 OSTEOTOME GFI JARIT 100185-1503

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR