BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 6090313 · Received November 9, 2016

    Report

    Report Number
    0008010177-2016-00265
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    April 8, 2014
    Report Date
    October 17, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 FOR RETURN.

    Description of Event or Problem · 1

    ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, A PATIENT UNDERWENT A PROCEDURE WHERE AN IMPLANT WAS USED TO REPAIR HIS MANDIBLE. SUBSEQUENTLY, THE PATIENT ALLEGES HE EXPERIENCED NERVE DAMAGE AS WELL AS DAMAGE TO HIS BONE STRUCTURE AND JAW INTEGRITY. NO FURTHER INFORMATION REGARDING THE PRODUCT HAS BEEN PROVIDED. AT THIS POINT, STRYKER IS UNABLE TO ASCERTAIN WHICH ONE OF ITS PRODUCTS WAS ACTUALLY USED AND WILL NOT BE ABLE TO OBTAIN THE PRODUCT EXCEPT WITHIN THE LITIGATION PROCESS, IF AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740415 UNKNOWN_FRO_PRODUCT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1