BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIUS MINI IMPLANTS

    MDR report key: 1484281 · Received September 28, 2009

    Report

    Report Number
    2242816-2009-00095
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Date of Event
    April 14, 2009
    Report Date
    September 14, 2009
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PARTS INVOLVED IN EVENTPART NO. LOT NO. MFG. DATE1200-1221 960590 11/13/2007 1200-9003 40816 06/03/2005

    Description of Event or Problem · 1

    DURING SURGERY, CROSS CONNECTOR AND SCREWDRIVER TIP BROKE WHILE APPLYING TORQUE. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTIUS MINI IMPLANTS TELESCOPING ARCHED CROSS CONNECTOR KWP EBI, LLC 921720

    Patients

    Seq Age Sex Outcome Treatment
    1