BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 TITANIUM SPINAL SYSTEM

    MDR report key: 3253905 · Received July 30, 2013

    Report

    Report Number
    0002242816-2013-00080
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    EBI, LLC.
    Product Code
    MNI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED SCREW FOUND A LARGE CRACK ALONG THE SCREW HEAD. A REVIEW OF THE MANUFACTURING FOR THE SCREWS INDICATED THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES REPORTED AT INSPECTION IN 2013. BASED ON THE CURRENT INFORMATION, THE MOST PROBABLY ROOT CAUSE OF THIS REPORTED INCIDENT IS OFF-AXIS TORQUING OF THE PLUG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE DURING TORQUING IN SURGERY. SUBSEQUENTLY, THE SCREW WAS EXPLANTED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355340 POLARIS 5.5 TITANIUM SPINAL SYSTEM 5.5 TI 7.5X45MM TRANSLATION MNI EBI, LLC. N/A 2345281

    Patients

    Seq Age Sex Outcome Treatment
    1