BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3020047 · Received March 25, 2013

    Report

    Report Number
    0009617544-2013-00097
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    December 22, 2010
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION. AN INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. FURTHER INVESTIGATION CANNOT BE PERFORMED. NO PRODUCT RETURN.

    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. DEVICE NOT RETURNED TO STRYKER.

    Description of Event or Problem · 1

    "IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2010 A C6-7 ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) SURGERY WAS PERFOMED. IT IS FURTHER ALLEGED THAT AFTER THE SURGERY THE PATIENT BEGAN EXPERIENCING EXTREME PAIN. A CT SCAN OF (B)(6) 2011 ALLEGEDLY REVEALED "HARDWARE FAILURE AND KYPHOTIC DEFORMITY" WHICH WAS REVISED ON (B)(6) 2011."

    Description of Event or Problem · 1

    "IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON DECEMBER 22, 2010 A C6-7 ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) SURGERY WAS PERFORMED. IT IS FURTHER ALLEGED THAT AFTER THE SURGERY THE PATIENT BEGAN EXPERIENCING EXTREME PAIN. A CT SCAN OF (B)(6) 2011 ALLEGEDLY REVEALED "HARDWARE FAILURE AND KYPHOTIC DEFORMITY" WHICH WAS REVISED ON (B)(6) 2011."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122515 UNKNOWN_SPINE_PRODUCT IMPLANT KWP STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention