BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IUNI G2

    MDR report key: 1952460 · Received January 4, 2011

    Report

    Report Number
    3004153240-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALANCER CHIP BROKE AFTER BEING TAPPED WITH A MALLET. THE SURGERY PROCEEDED WITHOUT INCIDENT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    BALANCER CHIP BROKE AFTER BEING TAPPED WITH A MALLET. THE SURGERY PROCEEDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR