BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS(TM) 5.5 SPINAL SYSTEM

    MDR report key: 2437825 · Received February 3, 2012

    Report

    Report Number
    0002242816-2012-00008
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 9, 2012
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT AVAILABLE. NO MANUFACTURING RECORDS CAN BE REVIEWED. HEALTHCARE FACILITY WILL NOT RELEASE PARTS FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE TWO BROKEN RODS. PATIENT OUTCOME: PATIENT EXPERIENCED PAIN PRIOR TO REVISION. NO ADVERSE EFFECTS REPORTED AS A RESULT OF THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS(TM) 5.5 SPINAL SYSTEM 5.5 MM DIA X 300MM KWP EBI, LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention