BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO SUBTALAR IMPLANT

    MDR report key: 1467804 · Received July 23, 2009

    Report

    Report Number
    1833506-2009-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Date of Event
    June 25, 2009
    Report Date
    July 22, 2009
    Manufacturer
    BIOPRO, INC.
    Product Code
    NDL
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENGTH, DIAMETER, AND DISTANCE BETWEEN THREADS WERE ALL WITHIN DESIGN SPECIFICATIONS. NOTHING WAS FOUND WRONG DIMENSIONALLY OR MATERIALLY WITH THE DEVICE. THE IMPLANT WAS DONE AS A LONE PROCEDURE. NO ADJUNCTIVE PROCEDURES WERE DONE SUCH AS AN ACHILLES LENGTHENING OR A GASTRIC RESECTION WHICH MAY HAVE PREVENTED THE IMPLANT FROM DISLODGING.

    Description of Event or Problem · 1

    PATIENT HAD EJECTED THE IMPLANT AND IT WAS RE-INSERTED. IT WAS THEN EJECTED AGAIN AFTER THE SURGERY. IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO SUBTALAR IMPLANT BONE FIXATION FASTENER NDL BIOPRO, INC. 17222 105737

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention