BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA JARIT

    MDR report key: 12438306 · Received September 8, 2021

    Report

    Report Number
    12438306
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 25, 2021
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    HXS
    UDI-DI
    10381780377627
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BULLDOG NEEDLEDRIVER: DURING THIS PROCESS THE TIP WAS DISCOVERED TO BE MISSING A PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337911 INTEGRA JARIT TWISTER, WIRE HXS INTEGRA LIFESCIENCES PRODUCTION CORPORATION 121-260 10381780377627

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA