BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATINE FOREHEAD 3.0

    MDR report key: 1222064 · Received November 3, 2008

    Report

    Report Number
    3003644133-2008-00021
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTRACTED TISSUE WAS ASSESSED BY A RESEARCH ENGINEER. HE OBSERVED A THICK LAYER OF TISSUE SURROUNDING A COHESIVE WHITE MATERIAL. THE SAMPLE WAS CUT THROUGH THE MIDSECTION TO EXAMINE THIS MATERIAL. WHEN SLIGHT PRESSURE WAS APPLIED, THE MATERIAL IMMEDIATELY CRACKED AND SPLINTERED INTO PIECES. VISUAL EXAMINATION SUPPORTED THE CONCLUSION THAT THIS WAS DEVICE POLYMER ENCAPSULATED BY TISSUE. THERE IS A VERY LOW INCIDENCE OF REPORTS WITH RESPECT TO REACTIONS AFTER SURGICAL PROCEDURES WITH ULTRATINE DEVICES (ABOUT 0.3% OF PRODUCT) .

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED TWO DEVICES IN 2008. ONE MONTH LATER, THE PATIENT COMPLAINED OF PAIN, HOWEVER, THERE WERE NO ISSUES REGARDING SWELLING OR DEVICE VISIBILITY. ON APPROX SEVEN AND A HALF MONTHS LATER, THE PHYSICIAN NOTED THAT A LUMP HAD DEVELOPED AND PROGRESSED OVER THE PRIOR MONTH. NO REDNESS WAS NOTED. SWELLING HAD DEVELOPED ON THE LEFT SIDE ONLY WHICH WOULD NOT SUBSIDE. THE PHYSICIAN EXTRACTED PIECES OF THE DEVICE ON SIX DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATINE FOREHEAD 3.0 SMOOTH METALLIC BONE FIXATION FASTNER HWC COAPT SYSTEMS, INC. 23201 01806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention