BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR RECON PLATE, 11 HOLE, STRAIGHT, WITH T

    MDR report key: 1833048 · Received September 13, 2010

    Report

    Report Number
    8010177-2010-00309
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS IN HIS LETTER THAT THE PLATE BROKE APPROX 6 MONTHS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBULAR RECON PLATE, 11 HOLE, STRAIGHT, WITH T IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other