BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3243620 · Received July 23, 2013

    Report

    Report Number
    0009617544-2013-00278
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    December 3, 2007
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED BY THE CUSTOMER THAT 6 RAY CAGES WERE IMPLANTED ON (B)(6) 1997 AND THE PATIENT IS STILL EXPERIENCING PAIN. TWO RAY CAGES ARE MEANT TO BE USED AT EACH LEVEL AND THE RAY CAGES ARE ONLY INDICATED FOR USE AT ONE OR TWO LEVELS ACCORDING TO THE INSTRUCTIONS FOR USE. RAY CAGES ARE NOT INDICATED FOR USE AT 3 LEVELS. IT WAS REPORTED THAT THE PATIENT HAD 6 CAGES IMPLANTED INDICATING THAT THIS SURGERY WAS PERFORMED AT THREE LEVELS. THIS DEVICE MISUSE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BUT NO PRODUCT SPECIFIC ISSUE HAS BEEN REPORTED OR CONFIRMED SO THE CAUSE OF PATIENT PAIN CANNOT BE DETERMINED. 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

    PATIENT REPORTS HAVING SEVERE PAIN OVER LAST 16 YEARS FROM HAVING SIX STRYKER RAY CAGES IMPLANTED. PATIENT BELIEVES THAT THESE CAGES WERE RECALLED BUT HE WAS UNABLE TO RESPOND TO THE RECALL BACK THEN.

    Description of Event or Problem · 1

    PATIENT REPORTS HAVING SEVERE PAIN OVER LAST 16 YEARS FROM HAVING SIX STRYKER RAY CAGES IMPLANTED. PATIENT BELIEVES THAT THESE CAGES WERE RECALLED BUT HE WAS UNABLE TO RESPOND TO THE RECALL BACK THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343686 UNKNOWN_SPINE_PRODUCT INSTRUMENT MAX STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other