BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL IMPACTOR HANDLE

    MDR report key: 2444647 · Received February 6, 2012

    Report

    Report Number
    3004153240-2012-00011
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HWA
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE IMPACTOR HANDLE BROKE DURING IMPACTION. THE CASE WAS COMPETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE REUSABLE IMPACTOR HANDLE BROKE DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL IMPACTOR HANDLE REUSABLE IMPACTOR HANDLE HWA CONFORMIS, INC. ED-00709003

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR