BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HEAD ASSEMBLY

    MDR report key: 4322615 · Received October 15, 2014

    Report

    Report Number
    3004153240-2014-00137
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 23, 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 DURING SURGERY AT THE POINT WHERE THE INSTRUMENT CONNECTS TO THE IMPACTOR HANDLE. SURGERY WAS COMPLETED. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT OF MATERIAL INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPEC.

    Description of Event or Problem · 1

    THE REUSABLE IMPACTOR HEAD BROKE DURING SURGERY AT THE POINT WHERE THE INSTRUMENT CONNECTS TO THE IMPACTOR HANDLE. SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656294 IMPACTOR HEAD ASSEMBLY REUSABLE IMPACTOR COMPONENT LXH CONFORMIS, INC. C130701

    Patients

    Seq Age Sex Outcome Treatment
    1