BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOCUFF SCREW WASHER

    MDR report key: 371303 · Received January 7, 2002

    Report

    Report Number
    9613278-2001-00015
    Event Type
    Other
    Date Received
    January 7, 2002
    Date of Event
    August 30, 2001
    Report Date
    October 25, 2001
    Manufacturer
    BIONX IMPLANTS LTD.
    Product Code
    MAI
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RETEAR OF ROTATOR CUFF 5 MONTHS POST OPERATIVELY WITH FRAGMENTATION OF WASHER INTO MANY PARTICLES CAUSING DAMAGE TO ARTICULAR CARTILAGE OF HUMERAL HEAD AND GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCUFF SCREW WASHER BIOABSORBABLE SOFT TISSUE FIXATION DEVICE MAI BIONX IMPLANTS LTD. 2357XX (LENGTH UNK) S0252

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention