BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS 5.5 INSTRUMENTS

    MDR report key: 4792309 · Received May 22, 2015

    Report

    Report Number
    0002242816-2015-00047
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    April 22, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POLARIS 5.5 DORSAL HEIGHT ADJUSTER, ITEM # 14-501680, LOT # PV115C WAS RETURNED TO (B)(4) FOR EVALUATION. VISUAL INSPECTION OF THE ITEM CONFIRMED THE REPORTED EVENT. THE TIP OF THE INSERTER SHOWS WEAR FROM USE, AND THE LOBES ARE ROUNDED AT THE TIPS CONSISTENT WITH ROTATIONAL FORCE AT THE TIPS WITHOUT THE PENTALOBE FEATURE BEING FULLY SEATED IN THE SCREW. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED; THERE WERE TWO NON-CONFORMANCES RELATED TO THE ACCEPTANCE OF THIS LOT, HOWEVER THERE IS NO INDICATION THAT THE NON-CONFORMANCES CONTRIBUTED TO THE EVENT. A VISUAL AND FUNCTIONAL EXAMINATION OF THE ITEM CONFIRMED THE REPORTED EVENT. THE MOST LIKELY CAUSE IS APPLIED TORQUE WHEN THE ADJUSTER WAS NOT FULLY SEATED IN THE SCREW HEAD. SUPPLEMENTAL REPORT TWO OF FOUR FOR THE SAME EVENT, REFERENCE 2242816-2015-00046-1 THROUGH -00049-1.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. FILE TWO OF FOUR FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THE SURGEON HAD SOME ISSUES PUTTING IN ILIAC SCREWS. SEVERAL DRIVERS STRIPPED DURING ATTEMPTED INSERTION RESULTING IN A FORTY-FIVE MINUTE SURGICAL DELAY. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335519 POLARIS 5.5 INSTRUMENTS SCREW INSERTER/DRIVER HXX EBI, LLC. N/A PV115C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization