BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 2079198 · Received May 5, 2011

    Report

    Report Number
    1030489-2011-00492
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    NVR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE, PROCODE NVR WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE, 510K # K060415 WAS CLEARED IN THE UNITED STATES. A CHIP OF PEEK HAS BEEN BROKEN OFF THE SPHERE AT THE LEVEL OF THE ATTACHMENT TO THE IMPLANT INSERTER. THE BREAKAGE OCCURRED AT THE END OF THE THREADED HOLE PORTION AND AT THE BOTTOM OF THE LATERAL HANDLING HOLE. THE CHIP PRESENTS CYLINDRICAL MARKS AROUND THE THREADED HOLE CORRESPONDING TO THE CONTACT WITH THE IMPLANT INSERTER. THE CHIP PRESENTS ALSO A CRACK STARTING FROM THE THREADED HOLE THROUGH THE HANDLING HOLE AND THE OUTSIDE SURFACE OF THE SPHERE. THE SPHERE PRESENTS A SHAVING AT THE LEVEL OF THE BREAKAGE ON THE OUTER SPHERE SURFACE. THIS SHAVING IS OPPOSITE TO THE HANDLING HOLE. THE LAST THREAD OF THE THREADED HOLE HAS BEEN SHORN OFF AND PERPENDICULAR TO THE SHAVING. THE PART RETURNED WAS FOUND BROKEN AT THE LEVEL OF THE ATTACHMENT WITH THE IMPLANT INSERTER. NO PRE-EXISTING DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE OBSERVATIONS OF THE CHIP AND THE BROKEN SECTION OF THE SPHERE (SHAVING AND SHEAR THREAD) SUGGEST THAT THE BREAKAGE IS CONSISTENT WITH AN OVER-LOADING OF THE PART AND THE ORIGIN OF THE OVER-LOADING CAN BE ATTRIBUTED TO THE APPLICATION OF A LATERAL LOAD ON THE IMPLANT INSERTER DURING THE IMPLANTATION OF THE SPHERE. THIS LATERAL LOAD COULD BE LINKED TO A MISALIGNMENT OF THE INSERTER WITH INTERVERTEBRAL DISC SPACE DURING IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINAL PROCEDURE, THE IMPLANT BROKE AND THEN DETACHED FROM THE INSERTER DURING INSERTION. THE IMPLANT WAS BROKEN INTO PIECES WITH FIRST HAMMERING DURING IMPLANTATION. ANOTHER IMPLANT WAS USED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATELLITE SPINAL SYSTEM NVR MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NB34

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR