BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS 5.5 TRANSLATION SCREW

    MDR report key: 4928847 · Received July 21, 2015

    Report

    Report Number
    0002242816-2015-00075
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 22, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    NKB
    PMA / PMN Number
    PK133746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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. REPORT TWO OF TWO FOR THE SAME EVENT, SEE ALSO 2242816-2015-00074.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A L5-S1 FUSION THE SURGEON IMPLANTED FOUR (4) SCREWS AND WAS PERFORMING FINAL TIGHTENING ON THE SCREWS. DURING FINAL TIGHTENING, THE FIRST SCREW BROKE COMPLETELY AT THE TULIP HEAD AND SHEARED OFF ONE SIDE OF THE TULIP. THE OTHER SCREWS KEPT SPLAYING PREVENTING FINAL TORQUE APPLICATION. THIS RESULTED IN A FORTY (40) MINUTE SURGICAL DELAY. AT THIS TIME, NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472127 POLARIS 5.5 TRANSLATION SCREW BONE SCREW NKB EBI, LLC. N/A 2338732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention