BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, BIO-INTERFERENCE, 10 X 28MM, FULL THREAD

    MDR report key: 633689 · Received September 8, 2005

    Report

    Report Number
    1220246-2005-00145
    Event Type
    Injury
    Date Received
    September 8, 2005
    Date of Event
    May 6, 2005
    Report Date
    September 2, 2005
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DURING AN ACL REVISION THE SURGEON REMOVED THE IMPLANT AND IT DID NOT HAVE ANY SIGNS OB BEING ABSORBED. THE IMPLANT HAD BEEN IMPLANTED FOR APPROX 17 MONTHS. IT IS UNK WHY THE IMPLANT WAS REMOVED FROM THE PT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DURING AN ACL REVISION THE SURGEON REMOVED THE IMPLANT AND IT DID NOT HAVE ANY SIGNS OF BEING ABSORBED. THE IMPLANT HAD BEEN IMPLANTED FOR APPROXIMATELY 17 MONTHS. IT IS UNK WHY THE IMPLANT WAS REMOVED FROM THE PT. NO ADDITIONAL INFO IS AVAILABLE. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, BIO-INTERFERENCE, 10 X 28MM, FULL THREAD BIO-ABSORBABLE IMPLANT MAI ARTHREX, INC. AR-1400TB 34894

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention