BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR L LUMBAR STAND ALONE- CAGE

    MDR report key: 3071427 · Received April 22, 2013

    Report

    Report Number
    3005525032-2013-00035
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVD
    PMA / PMN Number
    K120869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED FOR EVALUATION SINCE IT IS STILL IMPLANTED AS OF (B)(6) 2013. BASED ON THE X-RAYS PROVIDED, ONE OF THE THREE INTEGRATED FIXATION SCREWS THAT SERVED WHEN DEVICE IS USED AS STAND ALONE APPEARS TO HAVE BEEN FORCED THROUGH THE SPACER AND THEREFORE INSERTED TOO DEEP. THIS MAY BE AN INDICATOR THAT A FREEHAND TECHNIQUE FOR SCREW INSERTION WAS CONDUCTED WHERE SURGICAL TECHNIQUE PROMOTES THE USE OF THE AIOG (ALL IN ONE GUIDE) IF THE SCREWS ARE BEING INSERTED. USING THE AIOG PROPERLY CAN PREVENT THE POTENTIAL ADVERSE EVENT OF INSERTING THE SCREWS TOO DEEP. WHEN AOIG IS USED WITH DRIVERS, IT PROVIDES A DESIGN FEATURE TO AVOID THE SCREW DRIVING THROUGH THE PEEK. THE TIPS OF DRIVERS FEATURE BLACK LASER MARKS THAT ARE TO BE ALIGNED WITH THE AIOG IN ORDER TO VISUALLY CONTROL THE SCREW INSERTION AND THEN AVOID THE SCREW DRIVING THROUGH THE PEEK. THE BLACK LASER MARKING WILL ALIGN WITH THE AOIG WHEN THE SCREW HAS BEEN FULLY INSERTED. (NOTE: USE OF AIOG IS DEPENDENT UPON SUCCESSFUL VISUAL DETERMINATION OF WHEN THE LASER MARKINGS LINE UP.) THE EVENT AS REPORTED APPEARS TO BE MORE THE RESULT OF TECHNIQUE (FREEHAND) RATHER THAN A DEVICE PROBLEM. BY MANUALLY DRIVING THE SCREW, IT CANNOT BE EXCLUDED THAT THE SCREW WAS FORCED THROUGH THE SPACER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "THE SCREW ADVANCED THROUGH THE SPACER DURING SURGERY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173175 ANCHOR L LUMBAR STAND ALONE- CAGE IMPLANT OVD STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42