BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3171037 · Received June 14, 2013

    Report

    Report Number
    0009617544-2013-00228
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: NO LOT OR PRODUCT CODE FOR EVALUATION. RESULTS: THE CUSTOMER REPORTED EVENT OF A PSEUDOARTHROSIS WAS CONFIRMED VIA THE CORRESPONDENCE WITH THE SALES REP. THE SALES REP MENTIONED THAT THE PATIENT WAS EXPERIENCING LEG PAIN AND WENT TO THE DOCTOR TO GET X-RAYS. HE SAID FUSION OCCURRED AT THE BOTTOM OF THE CONSTRUCT BUT NOT AT THE TOP. REVISION SURGERY WAS PERFORMED WITH A NEW SET OF PRODUCTS. HOWEVER, IT IS UNKNOWN WHAT PRODUCTS WERE INVOLVED AND IT COULD NOT BE CONFIRMED WHETHER THE PRODUCTS CONTRIBUTED TO THE EVENT. THE EVENT RESULTED IN A REVISION SURGERY, WHICH HAS A SEVERITY RATING OF S3. NO X-RAYS OR ADDITIONAL PRODUCT INFORMATION WAS PROVIDED FOR THIS INVESTIGATION AND THE DEVICE REMAINS WITH THE PATIENT. CONCLUSION: NO X-RAYS OR ADDITIONAL PRODUCT INFORMATION WAS PROVIDED FOR THIS INVESTIGATION AND THE DEVICE REMAINS WITH THE PATIENT. THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS CONDUCTED BUT IT WAS REPORTED THAT THE IMPLANT DID NOT FAIL, PSEUDOARTHROSIS WAS NOT RELATED TO THE IMPLANTS.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS CONDUCTED BUT IT WAS REPORTED THAT THE IMPLANT DID NOT FAIL, PSUEDOARTHOSIS WAS NOT RELATED TO THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270785 UNKNOWN_SPINE_PRODUCT IMPLANT NKB STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R