BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOURED MANDIBULAR ANGLE - L

    MDR report key: 5003141 · Received August 14, 2015

    Report

    Report Number
    0008010177-2015-00191
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS DISCARDED AT THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN WHICH A MEDPOR DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THE CASE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538450 CONTOURED MANDIBULAR ANGLE - L IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN 6266

    Patients

    Seq Age Sex Outcome Treatment
    1 Other