BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSCREW

    MDR report key: 371327 · Received January 7, 2002

    Report

    Report Number
    9613278-2001-00011
    Event Type
    Other
    Date Received
    January 7, 2002
    Report Date
    June 30, 2001
    Manufacturer
    BIONX IMPLANTS LTD.
    Product Code
    MAI
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OSTEOCHONDRAL LESION WAS FIXATED WITH THREE 2.7 MM SMARTSCREW IMPLANTS. 5 MONTHS POST-OPERATIVELY REPEAT ARTHROSCOPY REVEALED SEVERAL SMALL FRAGMENTS OF BIOABSORBABLE SCREW LOOSE WITHIN THE PT'S JOINT. THE LOOSE FRAGMENTS WERE REMOVED FROM THE JOINT. FINALLY PT WAS DOING WELL AND WAS BACK TO THE PT'S RECREATIONAL SPORTS INCLUDING BIKING AND SWIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSCREW BIOABSORBABLE BONE FIXATION DEVICE MAI BIONX IMPLANTS LTD. DIAMETER 2.7MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention