BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONX IMPLANT

    MDR report key: 235586 · Received August 6, 1999

    Report

    Report Number
    MW1016906
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Date of Event
    June 17, 1999
    Report Date
    August 6, 1999
    Manufacturer
    BIONX IMPLANTS INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD SUDDEN, SEVERE PAIN AND RESTRICTED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX IMPLANT Implant BANKART TACK MAI BIONX IMPLANTS INC. * 178

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other