MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Muscle Weakness (1967); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 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 there was a deviation during a l1-s1 degenerative deformity case. The surgical system was mounted to the patient's right psis. The surgeon accurately executed the left l1-l3 trajectories and then moved to the right side. There was a medial deviation/breach with deficit at right l1 and l2. A drill and tap were used through the arm guide. Some screws were placed freehand as they belonged to a separate manufacturer. Pedicle size was noted to be very thin at less than 3 mm and the screws placed were more than 5. 5 mm. This was discussed with the surgeon during the procedure. There was no patient harm and the procedure was delayed less than an hour.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13451564
• MDR Text Key: 285236625
• Report Number: 3005075696-2022-00006
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse