BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CORE2 VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 3221544 · Received July 1, 2013

    Report

    Report Number
    2031966-2013-00032
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 1, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K090176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS NOT BEEN EXPLANTED. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AT THIS TIME. TESTING OF THE INSTRUMENT USED TO TIGHTEN THE LOCK SCREW WILL BE PERFORMED IN ADJUNCT TO TESTING OF THE EXPLANTED VBR DEVICE, ONCE THEY ARE RETURNED TO NUVASIVE. REVISION SURGERY IS PLANNED, BUT HAS NOT YET OCCURRED. WHEN REVISION SURGERY OCCURS AND THE PRODUCT IS RETURNED, INVESTIGATION WILL RESUME AND ANY RELEVANT INFORMATION WILL BE REPORTED. LABELING REVIEW NOTES THE FOLLOWING: "CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOAD ASSOCIATED WITH DELAYED UNION... IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A T10 CORPECTOMY ON (B)(6) 2013 DURING WHICH AN X-CORE2 VBR AND BILATERAL VIPER (DEPUY PEDICLE SCREWS WERE IMPLANTED). DURING A 2-MONTH FOLLOW-UP VISIT ON (B)(6) 2013, RADIOGRAPHS DEPICTED THE X-CORE2 VBR IMPLANT HAD REDUCED IN HEIGHT APPROXIMATELY 1 CM. IN ADDITION, THE INFERIOR END CAP OF THE VBR IMPLANT HAD SUBSIDED INTO THE T11 VERTEBRAL BODY. SERIAL RADIOGRAPHS WERE EVALUATED BY NUVASIVE TO CONFIRM THE INITIAL REPORT AS WELL AS TO DETERMINE THE DEGREE OF COLLAPSE. THE PATIENT EXPERIENCED AN OSTEOPOROTIC FRACTURE AT T11, BUT IS UNKNOWN IF THIS OCCURRED BEFORE OR AFTER THE VBR IMPLANT HEIGHT REDUCTION. THE PATIENT IS REPORTING SIGNIFICANT PAIN AS A RESULT OF THE FRACTURE AND VBR HEIGHT REDUCTION. REVISION SURGERY TO REPLACE THE VBR IMPLANT IS PLANNED, BUT HAS NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297550 X-CORE2 VERTEBRAL BODY REPLACEMENT DEVICE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP NUVASIVE, INC. 7180027 DR3080

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANTED:| DEPUY VIPER BILATERAL PEDICLE SCREWS