BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL IMPACTOR HANDLE

    MDR report key: 11667958 · Received April 14, 2021

    Report

    Report Number
    3004153240-2021-00047
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 13, 2021
    Manufacturer
    CONFORMIS, INC.
    Product Code
    OOG
    PMA / PMN Number
    K170226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT METAL PORTION OF THE IDENTITY IMPACTOR HANDLE FELL OFF AFTER IT HAD JUST BEEN USED WITH THE TIBIA BROOCH. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY BY COVERING THE FEMORAL AND TIBIAL COMPONENTS FOR PROTECTION AND IMPACTED THEM WITH THE MALLET. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL PORTION OF THE IDENTITY IMPACTOR HANDLE FELL OFF AFTER IT HAD JUST BEEN USED WITH THE TIBIA BROOCH. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY BY COVERING THE FEMORAL AND TIBIAL COMPONENTS FOR PROTECTION AND IMPACTED THEM WITH THE MALLET. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560089 ITOTAL IMPACTOR HANDLE KNEE ARTHROPLASTY IMPLANTATION SYSTEM OOG CONFORMIS, INC. ED-07827 G190901

    Patients

    Seq Age Sex Outcome Treatment
    1