BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERTO

    MDR report key: 2894407 · Received December 27, 2012

    Report

    Report Number
    3006283823-2012-00003
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    July 2, 2010
    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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STAPLE NOT RETURNED TO BE EVALUATED, AS IT WAS LEFT IN THE PT. A RETROSPECTIVE REVIEW OF ALL REVERTO COMPLAINTS WAS CONDUCTED TO ENSURE ACCURACY OF THE MDR DECISION.

    Description of Event or Problem · 1

    DURING A POST OP X-RAY, 3 WEEKS AFTER IMPLANTATION, THERE WAS EVIDENCE THAT THE STAPLE WAS BROKE. NO DECISION AS TO HOW OR WHEN THE STAPLE BROKE. SURGEON MADE A DECISION TO LEAVE THE STAPLE IN THE PT AS THERE WAS NO DISCOMFORT. THERE WAS NOTE IN THE FILE OF PT NONCOMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERTO JDR CORE ESSENCE ORTHOPAEDICS 320-3703 1768/14

    Patients

    Seq Age Sex Outcome Treatment
    1