BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSCREW

    MDR report key: 1200170 · Received October 1, 2008

    Report

    Report Number
    9613278-2008-00009
    Event Type
    Other
    Date Received
    October 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE LITERATURE, THERE ARE SOME REPORTED LATE BODY REACTIONS WITH PLLA IMPLANTS. ADDITIONALLY, SOME LATE BODY REACTIONS HAVE BEEN REPORTED TO MANUFACTURER, BUT OCCURRENCE OF SUCH CASES IS VERY LOW. IN THE IFU OF SMARTSCREW, IN THE SECTION PRECAUTION AND WARNINGS, IT IS STATED: "TRANSIENT LOCAL FLUID ACCUMULATION AND/OR SINUS FORMATION MAY OCCUR IN STERILE CIRCUMSTANCES. ASPIRATION (SIMPLE DRAINAGE) MAY YIELD IMPLANT REMNANTS AND USUALLY RESULTS IN HEALING OF THE SINUSES WITHOUT ADVERSE EFFECT TO FRACTURE HEALING." WE ARE EXPECTING TO GET A SURGEON'S REPORT DURING THE FIRST WEEK OF OCTOBER. WE WILL FOLLOW UP THIS REPORT IF SURGEON'S REPORT GIVES US ADDITIONAL INFORMATION FOR THE CASE.

    Description of Event or Problem · 1

    REACTION APPROX TWO YEARS AFTER IMPLANTATION OF THE SMARTSCREW. EVIDENCE BY LESION MEDIAL AND LATERAL SIDE OF IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSCREW BIOABSORBABLE BONE FIXATION DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other