BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOURED MANDIBULAR ANGLE - L

    MDR report key: 5006601 · Received August 13, 2015

    Report

    Report Number
    8010177-2015-00191
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 12, 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 EVAL. IF ADD'L INFO IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. PR # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PROCEDURE IN WHICH A MEDPOR DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, THE PT DEVELOPED AN INFECTION. THE SALES REP WAS NOT PRESENT DURING THE CASE. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536064 CONTOURED MANDIBULAR ANGLE - L IMPLANT FWP STRYKER ORTHOBIOLOGICS - MALVERN 6266

    Patients

    Seq Age Sex Outcome Treatment
    1 Other