BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATINE FOREHEAD 3.5

    MDR report key: 1032052 · Received February 28, 2008

    Report

    Report Number
    3003644133-2008-00005
    Event Type
    Injury
    Date Received
    February 28, 2008
    Report Date
    February 6, 2008
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A VERY LOW INCIDENCE OF REACTION TO IMPLANTATION OF THIS DEGRADABLE DEVICE. WE HAVE DISCUSSED THE SURGICAL PROCEDURE WITH THE PHYSICIAN. IN THE EVENT THAT THE DEVICE IS EXPLANTED, WE ARE REQUESTING THE RETURN OF EXTRACTED DEVICES FOR HISTOLOGICAL ANALYSIS. IN THIS INSTANCE, THE DEVICE WAS IMPLANTED IN THE MID FOREHEAD AREA, WHICH IS UNUSUAL AND NOT IN ACCORDANCE WITH RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE. HOWEVER, IT IS INCONCLUSIVE AS TO WHETHER THERE IS A RELATIONSHIP BETWEEN PLACEMENT AND APPARENT ENCAPSULATION. IF MORE INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TWO ULTRATINE DEVICES WERE IMPLANTED IN PT IN 2007. PT HAS REPORTED THAT DEVICES HAVE NOT ABSORBED AND ARE ENCAPSULATED. PT IS ALSO CLAIMING PAIN, SWELLING, NUMBNESS AND BLURRED VISION 10 MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATINE FOREHEAD 3.5 SMOOTH METALLIC BONE FIXATION FASTNER MAI COAPT SYSTEMS, INC. 23101 01466

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention