BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUVASIVE SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 1658756 · Received April 9, 2010

    Report

    Report Number
    2031966-2010-00006
    Event Type
    Other
    Date Received
    April 9, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 8, 2010
    Manufacturer
    NUVASIVE, INC
    Product Code
    KWP
    PMA / PMN Number
    K073278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PLATE DETERMINED IT PERFORMED AS INTENDED; THE LOCK MECHANISM AND FIXATION TEETH WERE INTACT. INSTRUCTIONS FOR USE INDICATE THAT "METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE." THE ROOT CAUSE(S) OF THE REPORTED LOOSENESS IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP REPORT WILL BE MADE.

    Description of Event or Problem · 1

    SURGERY OCCURRED ON (B)(6) 2010 INVOLVING DISCECTOMY AND PLACEMENT OF INTERBODY IMPLANTS AT L3-4, L4-5 AND L5-S1. THE AFFIX PLATE WAS THE MEANS OF STABILIZATION ACROSS L4-S1. A DURAL TEAR OCCURRED AT THE S1 NERVE ROOT AND WAS REPAIRED. OVERNIGHT THE PATIENT WAS REPORTED TO HAVE HEAVY EMESIS, RESULTING IN DAMAGING THE DURAL REPAIR INITIALLY CARRIED OUT. THE DURAL TEAR WAS AGAIN REPAIRED ON (B)(6) 2010; THE SURGEON NOTED THE AFFIX PLATE WAS RELATIVELY LOOSE. IT WAS REMOVED, REPLACED AND RETURNED TO NUVASIVE. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2010 DUE TO SHIFTING OF THE INTERBODY IMPLANT WHICH IMPINGED ON THE SPINAL CANAL. THE SURGEON DETERMINED THE AFFIX PLATE DID NOT PROVIDE SUFFICIENT STABILIZATION ON ITS OWN AND IMPLANTED PEDICLE SCREWS AT L4-S1. THE SECOND PLATE WAS DISCARDED FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE SPINOUS PROCESS PLATE SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP NUVASIVE, INC AFFIX II TU0255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other