BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3023472 · Received March 27, 2013

    Report

    Report Number
    0009617544-2013-00098
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ENTERED TO REPORT A SECOND ROD BREAKAGE ON A PATIENT WHO SUFFERED A FIRST ROD BREAKAGE IN (B)(6) 2012. THE PREVIOUS COMPLAINT WAS ADDRESSED THROUGH PER (B)(4). BASED ON THE ATTACHED X-RAY AND MAKING COMPARISON WITH THE ONE PROVIDED UNDER PER (B)(4) IT APPEARS THAT PATIENT WAS NOT REVISED AFTER THE FIRST EVENT. IN SUCH CONDITION IT CANNOT BE EXCLUDED AND ENTIRELY UNEXPECTED THAT THE CONTRA LATERAL SIDE OF THE CONSTRUCT YIELDED IN FATIGUE MODE APPROXIMATELY FIVE MONTHS LATER. THE CONSTRUCT WAS NO LONGER OPTIMAL TO COUNTER BALANCE THE REPEATED MONOTONOUS STRESSES AND STRAINS THAT WOULD BE GENERATED BY THE MAGNITUDE OF PATIENT PATHOLOGY (DEFORMITY). THE INFORMATION PROVIDED UNDER PER (B)(4) STATES THAT THE CONSTRUCT INITIALLY PUT IN PLACE IN (B)(6) 2007 AND WAS IN ORDER ON X-RAYS DATED (B)(6) 2011. UPON REVIEW OF X-RAYS, BOTH RODS WERE BROKEN AT A LEVEL THAT MATCHES WITH THE BIOMECHANICAL LOADS THAT WERE LIKELY APPLIED TO THIS CONSTRUCT GIVEN THE DEFORMITY THAT WAS CORRECTED. THEREFORE IT IS BELIEVED THAT THE SECOND ROD BREAKAGE ON THE OPPOSITE SIDE OF THE CONSTRUCT IS THE RESULT OF FATIGUE SPREADING ON A DEVICE SUBMITTED TO REPEATED AND MONOTONOUS STRESSES AND STRAINS (OF STRONG OR LOW INTENSITY) GENERATED BY THE PATIENT PATHOLOGY (DEFORMITY). THIS WAS ACCENTUATED BY THE INITIAL BREAKAGE OF ROD ON THE OPPOSITE SITE. SUCH BREAKAGE IS THEREFORE EXPECTED TO BE THE RESULT OF FATIGUE SPREADING ON A ROD IMPLANTED FOR OVER FIVE YEARS AND APPROXIMATELY FIVE MONTHS AFTER BREAKAGE OF ROD ON THE OPPOSITE SIDE. HOWEVER, THE 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. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, " ... THIS IS THE SECOND ROD BREAKAGE IN THE SAME PATIENT ... THE 1ST ROD BREAKAGE WAS REPORTED DURING PER 528-350053. PATIENT IS ON THE WAITING LIST TO REPLACE THE ROD."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, " ... THIS IS THE SECOND ROD BREAKAGE IN THE SAME PATIENT ... THE 1ST ROD BREAKAGE WAS REPORTED DURING PER (B)(4). PATIENT IS ON THE WAITING LIST TO REPLACE THE ROD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126354 UNKNOWN_SPINE_PRODUCT SPINAL ROD NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R