BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATINE FOREHEAD 3.0

    MDR report key: 1133385 · Received August 22, 2008

    Report

    Report Number
    3003644133-2008-00012
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 21, 2008
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN DID NOT RETURN THE DEVICE FOR EVALUATION. THE PHYSICIAN ACKNOWLEDGED THAT THIS IS THE FIRST SURGERY PERFORMED WITH THE ULTRATINE DEVICE. MORE INFORMATION WILL BE PROVIDED IF AVAILABLE.

    Description of Event or Problem · 1

    DR IMPLANTED TWO ULTRATINE FOREHEAD 3.0 DEVICES IN 2008. THE PATIENT CONTACTED THE OPERATING PHYSICIAN ON NINE DAYS LATER, REPORTING BROW PTOSIS. ON TWO MONTHS LATER, THE PHYSICIAN PERFORMED AN EXPLORATORY SURGERY, CLAIMED THAT THE POST OF THE DEVICE REMAINED IN THE DRILLED HOLE WHILE THE TINE SECTION OF THE DEVICE HAD MIGRATED MIDWAY DOWN FOREHEAD. THE PHYSICIAN REPLACED THE DISLODGED DEVICE WITH AN ENDOTINE FOREHEAD 3.0 DEVICE. THE PHYSICIAN DID NOT PROVIDE EXPLANTED DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATINE FOREHEAD 3.0 SMOOTH METALLIC BONE FIXATION FASTENER HWC COAPT SYSTEMS, INC. 23201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention