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

Model Number TPL0059

Device Problem Malposition of Device (2616)

Patient Problem Iatrogenic Source (2498)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a guidance device being used in a spinal procedure.It was reported that the trajectories were low on five of the last 6 cases.The hcp performed an mis tlif.The robot was sent to the l5 and s1 trajectories on the left and right, the skin was marked and then incision was made.The inner and outer drill guide was placed and the pedicle was drilled.The reduction tube was inserted and guidewires placed through the tubes.The c arm was brought in to verify guidewire placement.It was noted that the wires appeared low but should be ok.A tlif was performed and then screws inserted using fluoroscopy.On sunday (b)(6) 2019 the patient had to be brought back to the or to remove the l5 and s1 screws on the patients left side as they were low and the l5 screw appeared to be in the foramen.It was deemed that the screws on the patients right side were low but were still in the pedicle so were left in.There were no additional complications reported or anticipated as a result of the event.

Manufacturer Narrative

Evaluation of the returned software export files indicated that a skiving potential was possible at s1 left.The schnaz pin was inserted correctly to the psis and no major issues were detected.The investigation team could not find unambiguous cause for the deviation.The probable causes for these deviations can be related to potential skiving of the tools on the bone, platform shift that caused the screws to deviate in the same manner or surgical technique.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative indicated that the system was now working fine.They believed that the arm was replaced.

• 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: 8640738
• MDR Text Key: 146076739
• Report Number: 1723170-2019-02626
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• 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: 06/12/2019
• Date Device Manufactured: 09/01/2017
• 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 Outcome(s): Required Intervention