BEUDAMED
    FDA Adverse Event Other Summary report: N

    RECON FULL MANDIBULAR PLATTE, 6X13X6 HOLE, WITH TE

    MDR report key: 1810792 · Received August 19, 2010

    Report

    Report Number
    8010177-2010-00288
    Event Type
    Other
    Date Received
    August 19, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESE FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR RETURN. INTERNAL INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THEATRE NURSE REPORTS VIA OUR CUSTOMER SERVICE THAT THE TEMPLATE OF THE PRIMARY PRODUCT WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECON FULL MANDIBULAR PLATTE, 6X13X6 HOLE, WITH TE IMPLANT JEY STRYKER OSTEOSYNTHESE FREIBURG NA J5E00F1669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK