BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IUNI/IDUO TIBIAL IMPACTOR

    MDR report key: 1952401 · Received January 3, 2011

    Report

    Report Number
    3004153240-2011-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL IMPACTOR TIP BROKE OFF INSIDE THE IMPACTOR HANDLE. THERE WAS NO DELAY IN SURGERY OR ADVERSE IMPACT TO THE PATIENT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    TIBIAL IMPACTOR TIP BROKE OFF INSIDE THE IMPACTOR HANDLE. THERE WAS NO DELAY IN SURGERY OR ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IUNI/IDUO TIBIAL IMPACTOR TIBIAL IMPACTOR HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR