BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 4162075 · Received October 10, 2014

    Report

    Report Number
    0008010177-2014-00292
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 28, 1996
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 4 HOLE WURZBURG PLATE WAS INSERTED FOR ORIF FRACTURED MANDIBLE IN 1996. PLATE NOW REQUIRES REMOVAL DUE TO TYPE OF SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644682 UNKNOWN_FRO_PRODUCT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1