BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUVASIVE SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 1694437 · Received May 6, 2010

    Report

    Report Number
    2031966-2010-00008
    Event Type
    Other
    Date Received
    May 6, 2010
    Report Date
    April 22, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K073278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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 INFO BE OBTAINED, A FOLLOW-UP REPORT WILL BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF AN AFFIX PLATE AT L4-L5 ON (B)(6)-2010 THAT THE PATIENT EXPERIENCED SOME PAIN AND BRUISING AT THE SURGICAL SITE. RADIOGRAPHS NOTED THE PLATE WAS DISLODGED. REVISION SURGERY WAS PERFORMED ON (B)(6)-2010. THE AFFIX PLATE WAS REPLACED AND WAS VERIFIED TO BE INSTALLED TIGHTLY. THERE WERE NO COMPLICATIONS DURING OR AFTER THE REVISION 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 NNH200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other