BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPINAL SYSTEM

    MDR report key: 4881911 · Received July 1, 2015

    Report

    Report Number
    0002242816-2015-00069
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    September 18, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    NKB
    PMA / PMN Number
    PK141804
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT FIVE OF FIVE FOR THE SAME EVENT, REFERENCE 2242816-2015-00065-1, 2242816-2015-00066-1, 2242816-2015-00067-1 AND 2242816-2015-00068-1. AN ADDITIONAL LOT NUMBER FOR PART NUMBER 6451 WAS RECEIVED THAT WAS NOT INITIALLY REPORTED, REFERENCE 2242816-2015-00089.

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THE PATIENT REQUESTED THE EXPLANTED DEVICES, THEREFORE NO PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE WARNINGS IN THE PACKAGE INSERT STATE POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO: BENDING, LOOSENING OR FRACTURE OF THE IMPLANTS OR INSTRUMENTS. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. FILE FIVE OF FIVE FOR THE SAME EVENT, SEE ALSO 2242816-2015-00065, 2242816-2015-00066, 2242816-2015-00067 AND 2242816-2015-00068.

    Additional Manufacturer Narrative · 1

    THE RETURNED EXPLANTED DEVICES WERE VISUALLY EVALUATED, NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED THERE WERE NO REPORTED ISSUES WITH THE HARDWARE THAT WAS REMOVED WITH THE EXCEPTION OF ONE BROKEN SCREW (P/N 50-6109MP LOT 87472). THE ROOT CAUSE CANNOT BE FULLY DETERMINED. HOWEVER, IT IS LIKELY THAT THE SCREW FRACTURED DUE TO LOADING ON THE DEVICE OVER THE COURSE OF THE 4+ YEARS IT WAS IMPLANTED WITHOUT FUSION. AS DISCUSSED IN THE LABELING, THE SCREWS ARE NOT DESIGNED NOR LABELED FOR BEING THE SOLE MEANS OF SPINAL SUPPORT AND WILL EVENTUALLY BREAK OR FRACTURE IF SOLID FUSION IS NOT PRESENT. PER THE REPORTER AND THE TREATING PHYSICIAN, THE NONUNION CONTRIBUTED TO THE SCREW FRACTURING. THERE WERE NO MANUFACTURING ISSUES DETECTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. SUPPLEMENTAL REPORT FIVE OF SIX FOR THE SAME EVENT, REFERENCE 2242816-2015-00065-2, 2242816-2015-00066-2, 2242816-2015-00067-2, 2242816-2015-00068-2 AND 2242816-2015-00089-1.

    Description of Event or Problem · 1

    IT IS REPORTED THE ORIGINAL SURGERY WAS PERFORMED (B)(6) 2010. ON AN UNKNOWN DATE, THE PATIENT REPORTED WALKING IN THE MALL AND FELT A POP AND PAIN. PATIENT REPORTS PROCEEDING TO THE EMERGENCY ROOM WHERE A FRACTURED SCREW WAS IDENTIFIED. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 AND THE IMPLANTS WERE REMOVED; WITH THE EXCEPTION OF A PORTION OF THE SCREW WHICH COULD NOT BE REMOVED FROM THE PATIENT'S FIFTH LUMBAR VERTEBRA (L5). THE PATIENT'S CURRENT PHYSICIAN ALLEGEDLY INDICATES "THE MAIN FACTOR WAS THE NON-UNION, BUT DOES NOT HAVE A SPECIFIC CAUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424549 POLARIS SPINAL SYSTEM ROD NKB EBI, LLC. N/A 14685S

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R| S