BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERTO

    MDR report key: 2894413 · Received December 27, 2012

    Report

    Report Number
    3006283823-2012-00009
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    March 7, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CORE ESSENCE ORTHOPAEDICS
    Product Code
    JDR
    PMA / PMN Number
    K071477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TEST RESULTS FROM THE VENDOR WERE REVIEWED AND RESULTS MET SPECIFICATION. STAPLE WAS NOT RETURNED FOR EVALUATION. A RETROSPECTIVE REVIEW OF ALL REVERTO COMPLAINTS WAS CONDUCTED TO ENSURE ACCURACY OF THE MDR DECISION.

    Description of Event or Problem · 1

    SURGEON INDICATED THAT THE CAPITAL FRAGMENT MOVED AND THE STAPLE BACKED OUT. A SCREW WAS PUT IN AFTER REPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERTO JDR CORE ESSENCE ORTHOPAEDICS 320-3709 1988/1

    Patients

    Seq Age Sex Outcome Treatment
    1