BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSCREW ACL

    MDR report key: 665850 · Received January 10, 2006

    Report

    Report Number
    9613278-2006-00001
    Event Type
    Other
    Date Received
    January 10, 2006
    Date of Event
    November 29, 2005
    Report Date
    January 4, 2006
    Manufacturer
    LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL SURGERY THREE SMARTSCREW ACL INTERFERENCE SCREWS WERE SPLIT DURING THE OPERATION. ONE SCREW WAS LEFT INTO THE BONE. METAL SCREWS WERE USED IN ORDER TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSCREW ACL BIOABSORBABLE FIXATION DEVICE MAI LINVATEC BIOMATERIALS LTD. 237025 S00002132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other