MAZOR X SYSTEM
Report
- Report Number
- 3005075696-2022-00031
- Event Type
- Injury
- Date Received
- April 5, 2022
- Date of Event
- January 19, 2022
- Report Date
- June 30, 2022
- Manufacturer
- MAZOR ROBOTICS LTD
- Product Code
- OLO
- UDI-DI
- 07290109181158
- PMA / PMN Number
- K182077
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS ACCURATE. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ANALYSIS RESULTS OF THE SOFTWARE EXPORTS AND LOGS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3: ANALYSIS OF THE SOFTWARE EXPORTS FOUND THE COMPLAINT WAS CONFIRMED. ANALYSIS REVIEWED THE PLANNING OF THE EXECUTED TRAJECTORIES. NEITHER OF THE 4 TRAJECTORIES PLANS SHOWED ANY SIGNIFICANT SKIVING POTENTIAL, AS THERE WAS NO CORTICAL SLOPE LEADING MEDIALLY NOR LATERALLY ON THE TRAJECTORY PLAN. ANALYSIS REVIEWED THE MATCHING ACCURACY OF THE SYSTEM. THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED TO BE ACCEPTABLE. ANALYSIS REVIEWED THE IMAGES PROVIDED IN THE EXPORT FILE. POST-OP IMAGES CONFIRMED THAT ALL 4 SCREWS ON L3-L4 HAVE SHIFTED IN SUCH A MANNER THAT BOTH LEFT SCREWS WERE SHIFTED MEDIALLY, WHILE BOTH RIGHT SCREWS WERE SHIFTED LATERALLY. IN A LATER CORRESPONDENCE WITH A REPRESENTATIVE ¿ 2 ISSUES WERE RAISED: (1) REFUSED TO PARALYZE THE PATIENT DURING THE ROBOTIC PORTION OF THE CASE, AND (2) USED "VALLEY LAB" BOVIE, IN ORDER TO CONTROL BLEEDING, DURING THE MOUNTING PHASE (WHEN THE SCHANZ PIN WAS PLACED IN THE PSIS, THE ROBOT WAS ATTACHED TO THE PATIENT, THE SYSTEM WAS REGISTERED AND K-WIRES WERE PLACED). THESE TWO ISSUES MAY HAVE ACTED AS CONTRIBUTING FACTORS TO THE OBSERVED DEVIATIONS. AS REPORTED, "DURING THE INITIAL PROCEDURE, A SCHANZ PIN WAS PLACED IN THE LEFT PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT." COMMUNICATION WITH THE REPRESENTATIVE CONFIRMED THAT THE MOUNTING PLATFORM WAS CHECKED AND APPEARED TO BE RIGID AT MOUNTING. AN ACCURACY TEST WAS PERFORMED, AND NO ISSUES WERE REPORTED. LASTLY, THE SURGERY TABLE, SHOWED THE EXECUTION ORDER OF THE TRAJECTORIES, COUPLED WITH THE RELATIVELY CONSISTENT DIRECTION AND LENGTH OF THE SCREWS SHIFTS, WEAKENS THE ARGUMENT THAT THE SHIFTS COULD HAVE BEEN CAUSED BY A PLATFORM SHIFT. ANALYSIS CONCLUDED THAT THE ROOT CAUSE OF THE DEVIATIONS REPORTED WAS DUE TO A PATIENT SHIFT, RESULTING IN A MEDIAL DEVIATION OF THE LEFT SIDE TRAJECTORIES, AND A LATERAL DEVIATION OF THE RIGHT SIDE TRAJECTORIES ON ALL L3-L4 TRAJECTORIES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L3-L4 TLIF PROCEDURE. THE DEVIATION WAS FOUND DURING A POST-OP CT SCAN. THE SCAN SHOWED THAT THE LEFT SIDE SCREWS WERE SHIFTED MEDIAL AND THE RIGHT SIDE SCREWS WERE SHIFTED LATERAL TO PLAN BY 4-6 MM. DURING THE INITIAL PROCEDURE, A SCHANZ PIN WAS PLACED IN THE LEFT PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE SURGEON PLACED SCREWS WORKING FROM RIGHT TO LEFT STARTING AT L3. THE MANUFACTURER REPRESENTATIVE SUSPECTED THE DEVIATIONS WERE DUE TO A PATIENT SHIFT. A REVISION PROCEDURE WAS DONE TO REVISE THE SCREWS. THE REPRESENTATIVE NOTED THAT IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS RELATED TO THE DEVIATIONS.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT WAS NOT PARALYZED DURING THE PORTION OF THE CASE WITH THE GUIDANCE SYSTEM AND BOVIE WAS BEING USED WHEN THE SURGICAL SYSTEM WAS MOUNTED TO THE TABLE. ACCURACY OF THE SYSTEM WAS CHECKED AND THERE WERE NO ISSUES. THE MOUNT WAS CHECKED AND VERIFIED TO BE RIGID DURING THE PROCEDURE. THE REVISION WAS COMPLETED AND THE SCREWS WERE SUCCESSFULLY REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499494 | MAZOR X SYSTEM | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MAZOR ROBOTICS LTD | TPL0059 | 07290109181158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Required Intervention |