BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 3931362 · Received April 8, 2014

    Report

    Report Number
    2031966-2014-00023
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K093319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NUVASIVE REFERENCE (B)(4). REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO REMOVE AND REPLACE THE AFFECTED SCREWS AND REATTACH THE RIGHT IMPLANT ROD. THE EXPLANTED PARTS WERE NOT RETURNED FOR EVALUATION. THE PATIENT IS REPORTEDLY DOING WELL POST-REVISION WITH NO PERMANENT IMPAIRMENT OR INJURY. THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION SO THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. RADIOGRAPHS CONFIRM THE REPORTED EVENT, BUT IT IS UNCLEAR IN THE LOCK SCREW LOOSENING PRECIPITATED THE SCREW FRACTURE. IT IS ALSO UNK IF THE PATIENT'S MEDICAL HISTORY AFFECTED COMPLIANCE WITH THE SURGEON'S POST-OPERATIVE CARE INSTRUCTIONS. SIMILARLY, IT IS UNK IF THE PATIENT SUSTAINED AN IMPACT THAT CONTRIBUTED TO SCREW FRACTURE AND ROD DISLODGEMENT. SHOULD THE EXPLANTED PRODUCTS BE RETURNED, INVESTIGATION WILL RESUME AND ANY RELEVANT INFORMATION WILL BE REPORTED.

    Description of Event or Problem · 1

    A POSTERIOR CERVICAL STABILIZATION SURGERY WAS PERFORMED ON (B)(6) 2013. A FOLLOW-UP RADIOGRAPH IN (B)(6) 2014 SHOWED THAT THE LEFT 3.5X20MM MULTI-AXIAL SCREW IN THE C2 VERTEBRAL BODY HAD FRACTURED. IN ADDITION, THE RIGHT C2 SCREW'S LOCKING CAP SEPARATED FROM THE SCREW, ALLOWING THE SUPERIOR END OF THE RIGHT IMPLANT ROD TO DISLODGE. THE SEQUENCE OF THE BILATERAL IMPLANT FAILURE IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210364 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP NUVASIVE, INC. 7905320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention