BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HEAD ASSEMBLY

    MDR report key: 4359998 · Received December 15, 2014

    Report

    Report Number
    3004153240-2014-00175
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 15, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE IMPACTOR HEAD BROKE AT THE POINT WHERE THE COMPONENT ATTACHES TO THE IMPACTOR HANDLE. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT OF MATERIAL INDICATE THAT THE COMPONENT WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE REUSABLE IMPACTOR HEAD BROKE AT THE POINT WHERE THE COMPONENT ATTACHES TO THE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821735 IMPACTOR HEAD ASSEMBLY REUSABLE IMPACTOR COMPONENT LXH CONFORMIS, INC. C130701

    Patients

    Seq Age Sex Outcome Treatment
    1