BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE TRANSBLEPH 3.5

    MDR report key: 1736741 · Received June 18, 2010

    Report

    Report Number
    3003644133-2010-00007
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 8, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIAL WAS NOT RETURNED TO THE MFR, THEREFORE, AN INVESTIGATION TO DETERMINE FAILURE MODE COULD NOT BE CONDUCTED. 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 TWO DEVICES WERE IMPLANTED (B)(6) 2010. POST-OPERATIVELY, THE PT COMPLAINED OF PAIN AND PALPABILITY AND REQUESTED THAT THE DEVICES BE REMOVED. THE DEVICES WERE EXPLANTED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE TRANSBLEPH 3.5 SMOOTH METALLIC BONE FIXATION FASTENER HWC COAPT SYSTEMS, INC. CFD-080-0167 02535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention