BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDE, SURGICAL, INSTRUMENT

    MDR report key: 9115389 · Received September 25, 2019

    Report

    Report Number
    1030489-2019-01061
    Event Type
    Death
    Date Received
    September 25, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    FZX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: -PRODUCT ID: 873-004, UDI- (B)(4), 510K: EXEMPT, QTY: 1 -PRODUCT ID: 8730006, LOT: NG18H017, UDI- (B)(4), 510K: EXEMPT, QTY: 1 -PRODUCT ID: 873-136, UDI- (B)(4), 510K: K003928, QTY: 1 -PRODUCT ID: 873-005, UDI- (B)(4), 510K: EXEMPT, QTY: 1 ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REQUESTED A CANNULATED SCREW SET FOR AN ODONTOID FRACTURE REPAIR ON A PATIENT. IN PREVIOUS CONVERSATIONS, THE SURGEON REPORTED THAT HE KNEW THIS WAS AN OFF-LABEL USE OF THIS SCREW. ACCORDING TO SURGEON HE WAS THE FIRST PERSON IN THE STATE TO PUT THIS SCREW IN AND INSERT CEMENT THROUGH THE CANNULA. INTRA-OP, THE SURGEON USED A DRILL GUIDE TO PLACE A GUIDEWIRE IN THE BONE. AFTER THE GUIDEWIRE WAS PROPERLY PLACED, HE USED A (DISPOSABLE) DRILL BIT THAT HE PLACED OVER THE GUIDEWIRE AND THROUGH THE DRILL GUIDE. AS HE WAS REMOVING THE DRILL BIT, THE GUIDEWIRE CAME OUT OF THE HOLE HE HAD MADE TO FIXATE THE ODONTOID. AFTER THE GUIDEWIRE WAS REMOVED, THE SURGEON STATED THAT HE DID NOT WANT TO START OVER WITH THE DRILL GUIDE AND DECIDED TO INSTEAD PUT THE GUIDEWIRE BACK INTO THE HOLE BY ¿FEEL¿. HE DID NOT TAKE X-RAY IMAGES WHILE HE WAS DOING THIS. WHEN HE FINALLY TOOK AN X-RAY, THE X-RAY IMAGE APPEARED TO SHOW THAT THE GUIDEWIRE WAS WELL INTO THE BRAIN AND NOT CLOSE TO THE HOLE HE WAS WORKING IN PRIOR TO STARTING HIS HOLE. THE SURGEON THEN PLACED A SCREW TO FIXATE THE ODONTOID BY HAND. AT THAT POINT, ANESTHESIA WAS HAVING ISSUES WITH A REPORTED SUDDEN ELEVATED BLOOD PRESSURE AND THEY DECIDED TO GET THE PATIENT OUT OF THE OR AS QUICKLY AS THEY COULD. ON THE MORNING OF (B)(6) 2019 THE REP WAS MADE AWARE THAT THE PATIENT HAD DIED HOURS AFTER THE SURGERY WITH A REPORTED CAUSE OF DEATH A SUBARACHNOID HEMORRHAGE. THE SCREW WAS LEFT IN THE PATIENT. NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911851 GUIDE, SURGICAL, INSTRUMENT GUIDE, SURGICAL, INSTRUMENT FZX MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death| O