BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE FORMAGRAFT

    MDR report key: 2665962 · Received March 28, 2012

    Report

    Report Number
    2031966-2012-00035
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    February 4, 2008
    Report Date
    March 28, 2012
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQV
    PMA / PMN Number
    K050789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF ECTOPIC BONE GROWTH HAS NOT BEEN CONFIRMED RADIOGRAPHICALLY. NO INFO REGARDING CONFIRMATION OR DEGREE OF NERVE INJURY HAVE BEEN AVAILABLE FOR REVIEW. NO PATHOLOGIC SPECIMENS ARE AVAILABLE FOR REVIEW. NO PATHOLOGIC SPECIMENS ARE AVAILABLE FOR EVAL. NO DETAILS REGARDING THE INITIAL SURGERY HAVE BEEN AVAILABLE TO EVALUATE USE OF THE PRODUCT CONSISTENT WITH INSTRUCTIONS FOR USE. ROOT CAUSE OF THE REPORTED EVENT IS UNK. REVIEW OF DEVICE HISTORY RECORD INDICATES ALL SPECIFICATIONS WERE MET. LABELING REVIEW NOTES: "POSSIBLE ADVERSE REACTIONS MAY INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING...NEUROLOGICAL COMPLICATION, AND DEFORMITY AT SITE."

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY ON (B)(6) 2008 FOR IMPLANTATION OF AN UNDISCLOSED CONTRUCT AT UNK SPINE LEVELS (L4-L5 WERE INVOLVED, BUT OTHER LEVELS ARE NOT KNOWN). SHORTLY AFTER THIS DATE, PT BEGAN EXPERIENCING SIGNIFICANT PAIN. ON (B)(6) 2010, REVISION SURGERY OCCURRED TARGETING L4-L5 IN AN ATTEMPT TO ALLEVIATE RADICULOPATHY. THE CONSTRUCT WAS REMOVED. ECTOPIC BONE GROWTH WAS NOTED AT THAT TIME. IT IS UNCLEAR IF THE ECTOPIC GROWTH WAS REMOVED. PAIN HAS CONTINUED AND PERMANENT IMPAIRMENT AND DISABILITY ARE ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE FORMAGRAFT COLLAGEN BONE GRAFT MATRIX MQV NUVASIVE, INC. 5010205 FG-07-022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other