MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problems Positioning Failure (1158); Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned software export file indicated that the system worked as designed.No malfunctions were reported or alleged by the healthcare provider or the manufacturer representative.The surgery outcome, given the images provided within the export file, indicate that the trajectories were executed according to plan, without any issues observed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the surgeon planned a scoliosis procedure for 11 vertebrae from t4 to s2 with removal of hardware from l4 to s1 using pre-operation ct and fluoro registration.The procedure started at approximately 7:30 am with the surgeon opening the patient and doing decompressions from l1 to s1.The manufacturer representative indicated that there may be registration issues due to the bone removal, but the surgeon wanted to get the decompression out of the way.After the decompression was complete, the first segment was started.The representative recommended the most superior levels be done first since fluoro was in the field and the target was on and ready to go; however, the surgeon decided to remove the c-arm and continue with scan <(>&<)> plan.A schanz pin was used in the right psis for fixation and the o-arm acquisition was done.The surgeon left the room as soon as the marker was attached.When the surgeon was called back in the room to verify segmentation, they thought the o-arm field of view did not capture enough for the s2 alar screws so the surgeon asked for another spin to be done.When the representative went to import a new image acquisition, the system made them unmount.The o-arm was already around the patient with drape over the reference marker so a generic work volume was used.Screws at s2, l5 and l2 were planned.The l2 screw on the right side was red due to the generic work volume being used.The representative adjusted the trajectory 3 degrees laterally, which allowed for the trajectory to be reached.When at l2, the surgeon thought the trajectory was skiving and needed to be moved medial.The angle of the trajectory was lessened and the entire screw was moved lateral enough to allow the trajectory to be drilled.Fluoro was used to spot check all trajectories and they were all accurate.The second segment from t10 to l2 2as then started.The patient was large and very lordotic so it was difficult to get the marker and anatomy in the o-arm scan given the o-arm field of view and there being no preview function.The representative also mentioned that the patient arm boards were starting to interfere at the current level of the patient.A spin was done with the o-arm, but the one marker was cut out so a second spin was acquired.The second spin cut out a portion of the pedicle at l1 so a third spin was done.The third spin was acceptable.While removing the o-arm and bringing the c-arm back in the room, the power cord of the guidance system was knocked out from the wall outlet.Since the surgical system did not move, the images were able to be reimported without additional scans.Accuracy of the guidance system was verified by sending the arm to known anatomical landmarks.The system was accurate and the screws were able to be accurate placed for the second segment.The third segment for t3-t9 was completed using fluoro to ct registration.A single clamp was used and fixated at t6.All of the screws had mis towers on them and the bridge was placed midline in between towers.A 3define scan was done with the towel tucked as close to the towers as possible.Ap and oblique images were then taken, but the oblique image quality was poor and segmentation failed multiple times.An error message for the oblique image quality was displayed on the system.The representative tried moving the red dots as well as trying different levels.The surgical tech had to rotate towards lateral to complete segmentation.T3 and t4 were unreachable due to the tower height of the lower levels screws and kyphosis of the trajectories.The surgeon decided to freehand the superior levels and all screws were accurately placed.The guidance system was removed and the representative left the procedure while the rods were secured at approximately 6 pm.While the procedure was being finished, the patient coded and the surgeon had to do cpr on the patient in the operating room at approximately 7 pm.Initially the surgeon stated the patient died, but then clarified the patient had coded and still alive, but probably would not make it.The surgeon indicated the guidance system slowed them down to a point where the procedure took too long and added four hours to the case; however, the representative estimated there was an hour delay since there were multiple workflow challenges that had to be worked through during the procedure.The representative later reported the patient passed away several days later.Additional information received from a manufacturer representative reported they thought the o-arm and guidance system were out of the operating room when the patient coded.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative reported the patient's diagnosis was adult deformity and the surgeon had planned multi-level decompressions.The representative did not know if there was any evidence of internal bleeding or if the patient had any comorbidities.The patient did not have any reactions to anesthesia or the surgery.No surgical or operative notes were available.The representative noted that cpr was performed at some point during closing of the procedure according to the surgeon.It was unknown if an autopsy would be performed.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8593705
• MDR Text Key: 145787054
• Report Number: 1723170-2019-02234
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR