BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 6.35 IMPLANTS

    MDR report key: 1402147 · Received June 16, 2009

    Report

    Report Number
    2242816-2009-00054
    Event Type
    Malfunction
    Date Received
    June 16, 2009
    Date of Event
    May 29, 2009
    Report Date
    June 10, 2009
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PARTS RECEIVED: PART NO. LOT NO. MFG. DATE50-6112MP 21137 04/2006.

    Description of Event or Problem · 1

    SCREWHEAD DISENGAGED FROM THREADS/POST AND SLIPPED DOWN POST PRIOR TO TORQUING. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    REPORTED AS A PORT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS 6.35 IMPLANTS 6.5MM X 40MM POLARIS SCREW MNI EBI, LLC 51073

    Patients

    Seq Age Sex Outcome Treatment
    1