MAUDE Adverse Event Report: MAZOR ROBOTICS LTD RENAISSANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TPL0038

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Unspecified Nervous System Problem (4426)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided.The reported event was from the following literature article: du j, gao l, huang d, shan l, wang w, fan y, hao d, yan l.Radiological and clinical differences between robotic-assisted pedicle screw fixation with and without real-time optical tracking.European spine journal.2021: 30:142-150.Https://doi.Org/ 10.1007/s00586-020-06641-y.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: to study radiological and clinical differences between robotic-assisted pedicle screw fixation with and without real-time optical tracking.Patients who underwent lumbar internal fixation in our hospital from june 2017 to february 2020 were divided into tinavi group (with optical tracking) and renaissance group (without optical tracking) according to assisted technology.The imaging data of the patients were collected, and the accuracy of screw implantation was measured according to rampersaud a¿d grade.Clinical outcomes such as operative time, fluoroscopic time and radiations dose were also collected.A total of 376 patients were included, including 201 patients in the tinavi group with 968 screws implanted and 175 patients in the renaissance group with 822 screws implanted.The accuracy of "perfect" and "clinically acceptable" pedicle screw implantation in the tinavi group was 94.9%¿98.7%, respectively, while in the renaissance group was 91.2%¿94.5%, respectively.There was significant difference between the two groups (p < >0.05).The operative time and operative time per screw in the tinavi group were lower than those in the renaissance group.However, fluoroscopic time per screw and radiations dose of the tinavi group were significantly higher than those of the renaissance group.Optical tracking in robotic system appears to increase accuracy because of the ability to detect the real-time position of the patient.Although there are still many problems to be solved, robot with optical tracking system shows its great potential in clinical application.Reported events two patients undergoing lumbar internal fixation using the guidance system experienced deviations that required revision procedures due to the screw penetrating the pedicle cortex and stimulating the nerve root.The patient experienced neurological complications related to the screw.One patient undergoing lumbar internal fixation using the guidance system experienced post-operative infection.3 - 27 screws placed using the guidance system during lumbar internal fixations procedures were deviated and penetrated the pedicles cortex less than 2 mm.4 - 9 screws placed using the guidance system during lumbar internal fixations procedures were deviated and penetrated the pedicles cortex between 2 and 4 mm.5 - 36 screws placed using the guidance system during lumbar internal fixations procedures were deviated and penetrated the pedicles cortex more than 4 mm.The deviated screws were repositioned during the procedure.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: NEUROLOGICAL 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: 13625894
• MDR Text Key: 290769633
• Report Number: 3005075696-2022-00020
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention