BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1692187 · Received May 13, 2010

    Report

    Report Number
    2031966-2010-00010
    Event Type
    Other
    Date Received
    May 13, 2010
    Report Date
    May 12, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFO HAS BEEN PROVIDED TO IDENTIFY THE PRODUCT THAT ALLEGEDLY MALFUNCTIONED. NO PRODUCT HAS BEEN RETURNED AND NUVASIVE HAS BEEN UNABLE TO PERFORM AN ANALYSIS OF THE DEVICE IN QUESTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE REPORTER. NUVASIVE WILL CONTINUE TO INVESTIGATE THIS REPORT AND FOLLOW-UP INFO WILL BE PROVIDED IN THE EVENT IT IS OBTAINED.

    Description of Event or Problem · 1

    VERTEBRAL BODY FRACTURE WAS REPORTED FOLLOWING 2-LEVEL XLIF SURGERY WITHOUT POSTERIOR FIXATION IN A (B)(6) FEMALE. THE PT REPORTEDLY FELL SHORTLY AFTER THE XLIF SURGERY, BUT RADIOGRAPHS DID NOT REVEAL FRACTURES AT THAT TIME. PRIOR SURGERY HAD OCCURRED USING INTERSPINOUS SPACERS; SPACERS WERE REPORTED TO HAVE BEEN INEFFECTIVE NECESSITATING FURTHER SURGERY. IT IS UNK IF A REVISION SURGERY IS PLANNED. DATE OF INITIAL SURGERY IS UNK AS IS THE DATE OF THE XLIF SURGERY. THE INVOLVED PRODUCTS HAVE NOT BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NKB NUVASIVE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR