BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS 5.5 STANDARD IMPLANT KIT

    MDR report key: 2920487 · Received January 17, 2013

    Report

    Report Number
    0002242816-2013-00005
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 19, 2012
    Manufacturer
    EBI, LLC.
    Product Code
    KWP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED MULTI-AXIAL SCREW WAS PERFORMED AND FOUND THE SCREW TO HAVE SEVERAL LACERATIONS ACROSS THE SCREW SEAT. THE SCREW SEAT WAS ALSO FOUND TO BE "LOCKED" AT APPROXIMATELY 12 DEGREE ANGLE FROM THE SCREW SHAFT AXIS. THERE ARE NO OBSERVATIONS OF BREAKAGE OR FAILURES FOUND ON THE SCREW. A REVIEW OF THE MANUFACTURING RECORD INDICATED THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES REPORTED AT INSPECTION IN 2011. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED INCIDENT IS EXCESSIVE DEFLECTION FORCES LEADING TO LOSS OF MECHANICAL INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW REQUIRED REVISION SURGERY DUE TO POST-OPERATIVE POSITION MOVEMENT. 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
    26103 POLARIS 5.5 STANDARD IMPLANT KIT 6.5X45MM MULTIAXIAL SCREW KWP EBI, LLC. N/A J2479451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention