BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATINE FOREHEAD 3.0

    MDR report key: 1736699 · Received June 18, 2010

    Report

    Report Number
    3003644133-2010-00006
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 19, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    NDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIAL HAS NOT BEEN RETURNED TO THE MFR, THEREFORE, AN INVESTIGATION TO DETERMINE FAILURE MODE COULD NOT BE CONDUCTED. THE DEVICE IS NOT DESIGNED TO COMPLETELY ABSORB WITHIN THE DURATION OF TIME IMPLANTED. THE BATCH RECORD FOR THIS LOT HAS BEEN REVIEWED, WHICH CONTAINS NO ABNORMAL MFG EVENTS. THE COMPLAINT RATE FOR THIS LOT IS NOT ABNORMAL FOR THIS DEVICE. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PHYSICIAN IMPLANTED THE DEVICE (B)(6) 2009. THE DEVICE HAS NOT DISSOLVED. THE DEVICE WAS REMOVED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATINE FOREHEAD 3.0 SMOOTH METALLIC BONE FIXATION FASTENER NDL COAPT SYSTEMS, INC. 23201 02352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention