BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENISCUS ARROW

    MDR report key: 372613 · Received January 16, 2002

    Report

    Report Number
    9613278-2002-00003
    Event Type
    Other
    Date Received
    January 16, 2002
    Manufacturer
    BIONX IMPLANTS, LTD.
    Product Code
    MAI
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INCREASED MEDIAL JOINT LINE PAIN LESS THAN 6 WEEKS AFTER MENISCAL REPAIR. REPEAT ARTHROSCOPY CONFIRMED MENISCUS REPAIR FAILURE AND BREAKAGE OF THE ARROWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCUS ARROW BIOABSORBABLE SOFT TISSUE FIXATION DEVICE MAI BIONX IMPLANTS, LTD. 521116 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention