BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

    MDR report key: 4943517 · Received July 16, 2015

    Report

    Report Number
    2031966-2015-00041
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    April 1, 2013
    Report Date
    July 16, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K090176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND MAY HAVE BEEN DISCARDED AT THE USER FACILITY. ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED; HOWEVER, THE REPORTED EVENT IS CONSISTENT WITH PATIENT-RELATED FACTORS AS A CONTRIBUTOR. LABELING REVIEW: "CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: ...PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY." "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: ...FRACTURE OF THE VERTEBRA."

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF A VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SPANNING THE C3-C7 SPINE LEVELS, THE PATIENT REPORTED INCREASING PAIN. THE VBR WAS NOTED TO HAVE SUBSIDED INTO THE C3 VERTEBRAL BODY APPROXIMATELY SIX WEEKS AFTER SURGERY. REVISION SURGERY WAS PERFORMED IN WHICH THE ANTERIOR CERVICAL PLATE WAS REMOVED AND VBR WAS REPLACED. THE ANTERIOR CERVICAL PLATE WAS REPLACED WITH POSTERIOR PEDICLE SCREW FIXATION. NO MALFUNCTION OF THE DEVICE IS KNOWN TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463740 NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM MQP NUVASIVE, INC. 5962366

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other