BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENISCUS ARROW

    MDR report key: 385558 · Received March 28, 2002

    Report

    Report Number
    9613278-2002-00009
    Event Type
    Other
    Date Received
    March 28, 2002
    Date of Event
    March 16, 1999
    Report Date
    June 12, 2001
    Manufacturer
    BIONX IMPLANTS LTD.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THREE ARROWS WERE IMPLANTED IN 1999. MENISCUS ARROW TIP MIGRATED TOWARD SURFACE DURING PHYSICAL THERAPY, REMOVED DURING SUBSEQUENT SURGERY IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCUS ARROW BIOABSORBABLE SOFT TISSUE FIXATION DEVICE MAI BIONX IMPLANTS LTD. 5211**, EXACT INFORMATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention