BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSCREW

    MDR report key: 549124 · Received October 18, 2004

    Report

    Report Number
    9613278-2004-00015
    Event Type
    Other
    Date Received
    October 18, 2004
    Date of Event
    September 9, 2004
    Report Date
    October 7, 2004
    Manufacturer
    LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGERY 2004 FOR HALLUS VALGUS. DISCOVERED DISLOCATION OF GREAT TOE 5 DAYS POST-OPERATIVELY. RETURN TO SURGERY 1 WEEK LATER SCREW WAS SPLIT THE TWO. BOTH FRAGMENTS RETRIEVED AND WILL FOR EVALUATION. SURGEON USED DIFFERENT FIXATION TO FINALIZE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSCREW BIOABSORBABLE BONE FIXATION DEVICE MAI LINVATEC BIOMATERIALS LTD. 223524 S1232

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention