BEUDAMED
    FDA Adverse Event Death Summary report: N

    MD-MAX TRIPLE LEAD POLYAXIAL SCREW ASSEMBLY 7.5 X 50MM

    MDR report key: 5008986 · Received August 17, 2015

    Report

    Report Number
    3005739886-2015-00064
    Event Type
    Death
    Date Received
    August 17, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 21, 2015
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K141397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT POSSIBLE AS THE DEVICE REMAINS IMPLANTED AND COULD NOT BE RETURNED TO THE MANUFACTURER. ALTHOUGH THE DOCTOR DID NOT INDICATE PRODUCT MALFUNCTION AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, THE EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. INVESTIGATION IS IN PROCESS, UPON COMPLETION A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED. REVIEW OF MANUFACTURING HISTORY WAS NOT POSSIBLE AS THE LOT NUMBER IDENTIFICATION WAS NOT AVAILABLE. A TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT REVEAL ANY PREVIOUS REPORTS OF THIS NATURE. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION. NO PRODUCT IS AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. NO CONCLUSIONS CAN BE DRAWN IN REGARD TO THE ROOT CAUSE OF THE REPORTED EVENT. AS ROOT CAUSE COULD NOT BE DETERMINED AND THIS IS THE ONLY REPORT OF THIS NATURE RECEIVED, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L2-5 LATERAL LUMBAR SPINE FUSION USING THE MALIF LATERAL SPACER SYSTEM AND MD MAX TRIPLE LEAD MIS PEDICLE SCREW SYSTEMS, PERFORMED ON (B)(6) 2015. THE LATERAL PORTION OF THE PROCEDURE WAS COMPLETED FIRST WITH THREE MALIF INTERBODIES PLACED BETWEEN THE L2-5 VERTEBRAE. FOLLOWING PLACEMENT OF EIGHT (8) MD MAX TRIPLE LEAD MIS PEDICLE SCREWS, AN IMAGE WAS OBTAINED TO CHECK THE POSITIONING OF THE SCREWS. THE DOCTOR WAS NOT HAPPY WITH THE POSITION OF THE RIGHT SIDE L5 PEDICLE SCREW AND CHOSE TO REPOSITION. AFTER RE-MEASURING THE NEW TRAJECTORY AT RIGHT L5, IT WAS DETERMINED THE NEW TRAJECTORY ALLOWED FOR A LONGER IMPLANT, AND THE ORIGINAL 7.5MM X 35MM MD MAX TRIPLE LEAD SCREW WAS REPLACED WITH A 7.5MM X 50MM MD MAX TRIPLE LEAD PEDICLE SCREW. FOLLOWING PLACEMENT OF THE NEW SCREW, AN IMAGE WAS OBTAINED AND THE DOCTOR WAS ONCE AGAIN NOT SATISFIED WITH THE PLACEMENT AND A THIRD ATTEMPT WAS MADE WITH AN ACCEPTABLE OUTCOME. THE PROCEDURE PROCEEDED WITH PLACING THE TITANIUM RODS FOR FINAL FIXATION. WHILE PLACING THE RODS WITHIN THE TULIPS OF THE PEDICLE SCREWS, THE NEUROMONITORING PERSON NOTIFIED THE DOCTOR THAT ALL MOTOR SIGNALS WERE LOST FROM THE MONITORING LEADS. SHORTLY AFTER THAT, THE ANESTHESIOLOGIST NOTIFIED THE ROOM THAT THE PATIENT'S BLOOD PRESSURE HAD FALLEN. THE DOCTOR QUICKLY REMOVED THE RODS, BROKE OFF THE EXTENDED TABS FROM THE EIGHT MD MAX SCREWS, AND PROCEEDED TO CLOSE THE INCISION. THE PATIENT WAS TAKEN TO CT FOR FURTHER EVALUATION AND THE SALES REPRESENTATIVE WAS NOTIFIED THAT THE PROCEDURE WAS DONE FOR THE EVENING. THE FOLLOWING DAY, WHEN FOLLOWING-UP AT THE FACILITY ABOUT SCHEDULING THE PATIENT TO FINISH THE HARDWARE CONSTRUCT, THE SALES REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT HAD PASSED AWAY THE NIGHT BEFORE. ALTHOUGH THE DOCTOR DID NOT INDICATE PRODUCT MALFUNCTION AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, THE EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541342 MD-MAX TRIPLE LEAD POLYAXIAL SCREW ASSEMBLY 7.5 X 50MM TIPLE LEAD POLYAXIAL SCREW MNI PRECISION SPINE, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death