BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPIN, 2.0 X 30MM

    MDR report key: 1379389 · Received March 3, 2009

    Report

    Report Number
    9613278-2009-00004
    Event Type
    Other
    Date Received
    March 3, 2009
    Report Date
    February 9, 2009
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AN INVESTIGATION CANNOT BE PERFORMED BECAUSE THE DEVICE REMAINS IMPLANTED. CONMED LINVATEC IS REPORTING THIS EVENT DUE TO ITS ASSOCIATION WITH THE SMARTPIN. IT WAS REPORTED THAT THE FOLLOW-UP X-RAY SUGGESTS THAT ONE DISSOLVING PIN IS CAUSING THE MEDIAL PROMINENCE.

    Description of Event or Problem · 1

    ABOUT 10 MONTHS FOLLOWING SURGERY FOR A LEFT CHEVRON BUNIONECTOMY (USING TWO SMARTPIN -IMPLANTS) AND OSTEOECTOMY OF THE 5TH METATARSAL HEAD, THE PATIENT PRESENTED WITH A SMALL PROMINENCE ON THE MEDIAL ASPECT OF THE FOOT NEAR THE BUNION AREA ALONG WITH PAIN IN THE AREA OF BUNIONECTOMY AND THE 5TH METATARSAL HEAD. IN ADDITION, SHE ALSO HAD PAIN ON THE PLANTAR ASPECT OF THE FOOT WITH TINGLING IN THE MIDDLE THREE TOES AND REDUCED RANGE OF MOTION IN THE FIFTH TOE. AT THIS TIME, NO FURTHER SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPIN, 2.0 X 30MM PIN, FIXATION, SMOOTH MAI CONMED LINVATEC BIOMATERIALS LTD. NA S0002805

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR