BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 IMPLANTS

    MDR report key: 1895460 · Received November 10, 2010

    Report

    Report Number
    2242816-2010-00169
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NO.: 94673, LOT NO.: 923310; LARGE CROSS CONNECTOR; MFG. DATE: 05/25/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO LOCK DOWN THE CROSS CONNECTOR, THE MIDDLE LOCKING DEVICE WOULD NOT ENGAGE. THE CROSS CONNECTOR WAS REMOVED AND REPLACED. THE SECOND CROSS CONNECTOR EXPERIENCED THE SAME ISSUE AND WAS REMOVED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS 5.5 IMPLANTS LARGE CROSS CONNECTOR MNH EBI, LLC 2214971

    Patients

    Seq Age Sex Outcome Treatment
    1