BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESPACE BONE CORT CAN 9X14X11.5MM LORDO

    MDR report key: 5686617 · Received May 27, 2016

    Report

    Report Number
    3005673311-2016-00090
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    April 28, 2016
    Report Date
    March 23, 2017
    Manufacturer
    CONTRACT MANUFACTURER: RTI SURGICAL
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DOCUMENTATION INDICATED THAT THIS ISSUE WAS RELATED TO INTERNAL PRODUCTION OF "SETS" AT AESCULAP INC. CORRECTIVE/PREVENTIVE ACTION WAS INITIATED AT AESCULAP INC. TO ENSURE THIS ISSUE DOES NOT RECUR.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE RECEIVED SETS CONTAINING EXPIRED ALLOGRAFT ON (B)(6) 2016 FOR USE IN A CASE. THE SETS CONTAINED ADEQUATE PRODUCT TO COMPLETE THE SURGERY AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339837 CESPACE BONE CORT CAN 9X14X11.5MM LORDO ALLOGRAFT JDN CONTRACT MANUFACTURER: RTI SURGICAL ME649 101086323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other