BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3010795 · Received March 19, 2013

    Report

    Report Number
    0009617544-2013-00083
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION SINCE IT WAS DISCARDED. AS A RESULT THE EXACT PRODUCT REFERENCE AND LOT NUMBER COULD NOT BE KNOWN WHICH MADE A THOROUGH INVESTIGATION IMPOSSIBLE TO COMPLETE. CONCLUSION: THE PEDICLE MARKER USE IS SOMEWHERE SIMILAR TO THE USE OF PROBES AS THEIR FUNCTIONS ARE SIMILAR. THIS IS AN INSTRUMENT HELPING THE SURGEON TO ASSESS THE DIRECTION OF THE PEDICLE, ITS INTEGRITY AND LENGTH IN ORDER TO DETERMINE THE ADEQUATE SCREW SIZE LATER ON. IN THIS EVENT, IT HAS BEEN REPORTED THAT A PEDICLE MARKER BROKE INSIDE L4 LEFT SIDE OF PATIENT. BROKEN PART WAS RETRIEVED AND REMOVED FROM PATIENT. THE BROKEN TIP WAS THEREFORE OBVIOUSLY NOT LEFT IN THE PEDICLE, NOR IN THE PATIENT. NO FURTHER ADVERSE CONSEQUENCES BESIDES 10 MINUTES ADDITIONAL SURGERY TIME WERE REPORTED FOR THE PATIENT. THE CONDITIONS IN WHICH THE BREAKAGE OCCURRED ARE NOT KNOWN. THE INSTRUMENT BREAKAGE IS BELIEVED TO BE THE RESULT OF THE CONDITION OF USE. DEVICE WAS DISPOSED OF AT HOSPITAL.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR A PEDICLE MARKER WHICH BROKE INSIDE THE L4 LEFT SIDE OF THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, BESIDES A TEN MINUTE DELAY OF SURGERY, REPORTED. NO PRODUCT WAS RECEIVED FOR EVALUATION SINCE THE HOSPITAL DISPOSED OF THE PRODUCT AND THE REPRESENTATIVE WATCHED IT GO IN THE GARBAGE. AS THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT, THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN. NO PRODUCT WAS RECEIVED AS THE HOSPITAL DISPOSED OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT... "A PEDICLE MARKER BROKE INSIDE L4 LEFT SIDE OF PATIENT. BROKEN PC. WAS RETREIVED AND REMOVED FROM PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT.. "A PEDICLE MARKER BROKE INSIDE L4 LEFT SIDE OF PATIENT. BROKEN PC. WAS RETREIVED AND REMOVED FROM PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114160 UNKNOWN_SPINE_PRODUCT INSTRUMENT LXH STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR