BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 SYSTEM IMPLANTS

    MDR report key: 2225813 · Received August 29, 2011

    Report

    Report Number
    2242816-2011-00102
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 2 OF 4 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDRS: 2242816-2011-101, 2242816-2011-103, 2242816-2011-104.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN XRAY IDENTIFIED A FRACTURED SCREW. PHYSICIAN DECIDED TO LEAVE THE SCREW IMPLANTED AS THERE HAS BEEN NO ADVERSE EFFECT OR OTHER ISSUES ASSOCIATED WITH THE EVENT. 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 SYSTEM IMPLANTS 45MM ROD KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR