BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 4796326 · Received May 26, 2015

    Report

    Report Number
    0009617544-2015-00236
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. LOT CODE NOT PROVIDED. RESULTS: THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN REVISED DUE TO A NARROWING OF THE PATIENT'S VERTEBRAL SPACE UNRELATED TO PRODUCT. CONCLUSION: NO FAILURE OR FAULT OF THE DEVICE WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT XIA LP REVISION SURGERY WAS PERFORMED. PRIMARY SURGERY DATE IS UNKNOWN. IN PRIMARY SURGERY, PLF OF L4-5 WAS PERFORMED. IN REVISION SURGERY, FIXATION WAS CHANGED TO PLIF OF L5-S WITH OIC PEEK BECAUSE L5-S INTERVERTEBRAL HAD BECOME NARROWER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT XIA LP REVISION SURGERY WAS PERFORMED. PRIMARY SURGERY DATE IS UNKNOWN. IN PRIMARY SURGERY, PLF OF L4-5 WAS PERFORMED. IN REVISION SURGERY, FIXATION WAS CHANGED TO PLIF OF L5-S WITH OIC PEEK BECAUSE L5-S INTERVERTEBRAL HAD BECOME NARROWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339028 UNKNOWN_SPINE_PRODUCT UNKNOWN SPINE PRODUCT MNI STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention