BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS 5.5 TITANIUM SPINAL SYSTEM

    MDR report key: 4090358 · Received September 15, 2014

    Report

    Report Number
    0002242816-2014-00071
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 18, 2014
    Report Date
    November 25, 2014
    Manufacturer
    EBI, LLC.
    Product Code
    MNI
    PMA / PMN Number
    PK123549
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. PER THE PRODUCT EVALUATION REPORT (PER), A VISUAL EXAMINATION CONFIRMED THE REPORTED EVENT. ONE OF THE TWO TABS OF THE SCREW HEAD WAS FRACTURED OFF AND THE INTERNAL THREADS OF THE SCREW HEAD EXHIBITED SIGNIFICANT DEFORMATION. THE ENGINEER FURTHER STATED THAT WHILE THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE DEVICE FAILURE IS AT LEAST PARTIALLY ATTRIBUTABLE TO IMPROPER SEAT/ALIGNMENT OF THE COUNTER TORQUE INSTRUMENT PRIOR TO FINAL TIGHTENING OF THE PLUG IN THE SCREW. THIS ROOT CAUSE WAS PREVIOUSLY IDENTIFIED IN AN INTERNAL CORRECTIVE ACTION. A CHANGE TO THE SCREW HEAD WAS IMPLEMENTED AND IT WAS DETERMINED THAT THIS SCREW WAS MANUFACTURED PRIOR TO THE CHANGES. ACCORDING TO THE PER, THE INVESTIGATION HAS NOT IDENTIFIED A MANUFACTURING ISSUE OR FAILURE TREND ASSOCIATED WITH THE UPDATED DESIGN.

    Additional Manufacturer Narrative · 1

    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. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TULIP HEAD OF THE SCREW BROKE UPON FINAL TIGHTENING. THE BROKEN SCREW, SIZE 7.5X35MM, WAS REPLACED WITH A LARGER SCREW 7.5X40MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568508 POLARIS 5.5 TITANIUM SPINAL SYSTEM 5.5 TI 7.5X35MM TRANSLATION MNI EBI, LLC. N/A 2395631

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability