BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 TITANIUM SPINAL SYSTEM

    MDR report key: 3040957 · Received April 8, 2013

    Report

    Report Number
    0002242816-2013-00031
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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
    NY, 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 SCREWS AND PLUGS FOUND SOME WEAR AND TEAR MARKINGS ALONG THE THREADING AND ON THE SCREW HEAD. FUNCTIONAL TESTING FOUND THAT THE PLUGS WERE CAPABLE OF FULLY THREADING ONTO THE SCREWS WITHOUT ISSUE. A REVIEW OF THE MANUFACTURING RECORD FOR THE SCREWS INDICATED THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES REPORTED AT INSPECTION IN 2013. RECORDS INDICATE THE IMPLANT PASSED ALL INSPECTION CRITERIA AT THE ESTABLISHED SAMPLING RATES. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED INCIDENT IS OFF-AXIS LOADING DURING TORQUING OF THE PLUG. IT WAS NOTED THAT THE SURGEON DID NOT USE THE RECOMMENDED COUNTER-TORQUE AT THE TIME OF THE REPORTED INCIDENT AND THAT MAY HAVE LEAD TO THE OFF-AXIS LOADING OF THE PLUG. THE SURGICAL TECHNIQUE STATES: "AFTER PROVISIONAL TIGHTENING, PROPER IMPLANT PLACEMENT SHOULD BE CONFIRMED WITH RADIOGRAPHS. THE PLUGS ARE THEN TIGHTENED WITH THE TORQUE LIMITING WRENCH IN COMBINATION WITH THE TORQUE STABILIZER." THE SURGICAL TECHNIQUE ALSO NOTES: "USE THE TORQUE LIMITING WRENCH IN COMBINATION WITH THE TORQUE STABILIZER FOR PROPER FINAL TIGHTENING OF THE HELICAL FLANGE PLUGS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW SPLAYED 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
    143350 POLARIS 5.5 TITANIUM SPINAL SYSTEM 5.5 TI 6.5X45MM TRANSLATION MNI EBI, LLC. N/A 2345221

    Patients

    Seq Age Sex Outcome Treatment
    1