BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION(TM) DCF SIZING CALIPER

    MDR report key: 2576989 · Received May 16, 2012

    Report

    Report Number
    1043534-2012-00402
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Report Date
    August 7, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. DURING A RETROSPECTIVE REVIEW OF FILES, WE DETERMINED THIS INCIDENT TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT.

    Description of Event or Problem · 1

    ALLEGEDLY DURING SALES TRAINING, THE CALIPER WOULD NOT FIT WITH MATING PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION(TM) DCF SIZING CALIPER KNEE INSTRUMENT KTZ WRIGHT MEDICAL TECHNOLOGY, INC. 070785754

    Patients

    Seq Age Sex Outcome Treatment
    1