BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL/PCL MODULAR SYSTEM

    MDR report key: 518988 · Received April 1, 2004

    Report

    Report Number
    2027970-2004-00002
    Event Type
    Injury
    Date Received
    April 1, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    HRX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF 8MM FEMORAL TUNNEL GUIDE OF ACL (ARTHROTEK) KIT SNAPPED OFF. TOO POSTERIOR TO EXTRACT, BREAK OCCURRED WITH MINIMAL POSITIONING AND POSTERIOR DISPLACEMENT OF FIBULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL/PCL MODULAR SYSTEM FEMORAL AIMER TIP HRX ARTHROTEK, INC. NA 772990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other