BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CMF_PRODUCT

    MDR report key: 3183083 · Received June 21, 2013

    Report

    Report Number
    0008010177-2013-00128
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED.

    Description of Event or Problem · 1

    SALES REP RECEIVED A CALL FROM OR STAFF AND THEY LET HIM KNOW THAT THEY HAD TO REMOVE A MANDIBLE PLATE DUE TO PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283707 UNKNOWN_CMF_PRODUCT IMPLANT JEY STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1