BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATH(R) THREAD CUP ADAPTOR

    MDR report key: 3828059 · Received May 22, 2014

    Report

    Report Number
    3010536692-2014-00861
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY TIPS ARE GETTING STUCK ON THE THE ADAPTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305769 PATH(R) THREAD CUP ADAPTOR HIP INSTRUMENT KWA MICROPORT ORTHOPEDICS INC. 1314793

    Patients

    Seq Age Sex Outcome Treatment
    1