BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 STANDARD IMPLANT KIT

    MDR report key: 2420348 · Received January 18, 2012

    Report

    Report Number
    0002242816-2012-00006
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    EBI, LLC
    Product Code
    HWC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED DURING THE PROCEDURE. THE SCREW WAS REMOVED AND REPLACED WITH NO FURTHER INCIDENT. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED DURING THE PROCEDURE. THE SCREW WAS REMOVED AND REPLACED WITH NO FURTHER INCIDENT. 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 STANDARD IMPLANT KIT 6.5X40MM MULTIAXIAL SCREW HWC EBI, LLC N/A J2436039

    Patients

    Seq Age Sex Outcome Treatment
    1