BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES

    MDR report key: 1911082 · Received November 24, 2010

    Report

    Report Number
    8010177-2010-00449
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SALES REP WAS INVOLVED IN A MANDIBLE FRACTURE CASE ON (B)(6)2010. EVERYTHING WENT AS PLANNED DURING SURGERY AND THERE WERE NO COMPLICATIONS. THE REP CALLED TODAY TO INFORM US THAT THE PT IS SCHEDULED FOR A RE-OP LATER TODAY DUE TO INFECTION. SHE DOES NOT HAVE FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other