BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPRO HORIZON SUBTALAR IMPLANT

    MDR report key: 2651994 · Received July 3, 2012

    Report

    Report Number
    1833506-2012-00002
    Event Type
    Other
    Date Received
    July 3, 2012
    Date of Event
    April 27, 2012
    Report Date
    July 2, 2012
    Manufacturer
    BIOPRO, INC.
    Product Code
    NDL
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBILITY THAT SOFT TISSUE OR OTHER FOREIGN BODY FOUND ITS WAY BETWEEN THE DRIVER AND THE IMPLANT CAUSING A PROBLEM. POSSIBLE THAT A KINK OR BEND IN THE GUIDE WIRE HAPPENED DURING SURGERY WHICH MAY HAVE CAUSED THE SEATING OF IMPLANT TO BE OFF.

    Description of Event or Problem · 1

    PT HAD SURGERY TO IMPLANT SUBTALAR. TWO DAYS LATER, IMPLANT WAS REMOVED BECAUSE, IT WAS NOT SEATED PROPERLY. SURGEON REPLACED IT WITH A COMPETITOR'S IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO HORIZON SUBTALAR IMPLANT SUBTALAR NDL BIOPRO, INC. 17222 110270

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention