MAZOR X SYSTEM
Report
- Report Number
- 3005075696-2021-00071
- Event Type
- Malfunction
- Date Received
- June 7, 2021
- Date of Event
- May 18, 2021
- Report Date
- October 20, 2021
- Manufacturer
- MAZOR ROBOTICS LTD
- Product Code
- OLO
- UDI-DI
- 07290109180465
- PMA / PMN Number
- K182077
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
H3: ANALYSIS OF THE SURGICAL ARM FOUND THE COMPLAINT WAS CONFIRMED. VISUAL/PHYSICAL EXAMINATION AND FUNCTIONAL TESTING FOUND JOINT 6 HAD HIGH CURRENT CONSUMPTION AND THE REPEATER CARD FAILED. THE SURGICAL ARM WAS REPAIRED, RECALIBRATED AND PASSED ALL TESTING. 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 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 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.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS DETERMINED THE BED WAS UNPLUGGED AND THE BOVIE GROUNDED THROUGH THE GUIDANCE SYSTEM.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE ISSUE WAS RESOLVED AFTER REPLACING THE SURGICAL ARM.
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206, SERIAL/LOT #: (B)(4) , UBD: , UDI#: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SURGICAL ARM WAS REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ANALYSIS RESULTS OF THE SURGICAL ARM 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.
MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. THE FIRST SECTION OF THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE SURGEON REPOSITIONED THE SURGICAL SYSTEM TO DO THE SECOND SEGMENT. WHEN TAKING AN IMAGE FOR THE SYSTEM, THE SURGEON WAS USING BOVIE AT THE SAME TIME. THE BOVIE DID NOT TOUCH THE SURGICAL ARM, BUT A JOINT 6 ERROR WAS DISPLAYED AND THE ARM COULD NOT BE MOVED TO PREDEFINED LOCATIONS. THE ERROR MESSAGE INDICATED THAT MAINTENANCE WAS REQUIRED. THE MANUFACTURER REPRESENTATIVE WENT INTO THE SUPERUSER SETTINGS AND RESET THE MOVEMENT OF THE SURGICAL ARM, BUT THE ARM COULD NOT BE SENT TO A TRAJECTORY. THE REPRESENTATIVE RESET THE MOVEMENT AGAIN AND THE SURGICAL ARM COULD BE SENT TO THE CLEAR UP POSITION. WHEN SENDING THE SURGICAL ARM TO THE TRAJECTORY, THE ARM WAS INACCURATE. A 3 POINT ACCURACY CHECK WAS DONE AND THE TEST WAS INACCURATE. SOFT AND HARD REBOOTS OF THE SYSTEM DID NOT RESOLVE THE ISSUE. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND NAVIGATION WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847993 | MAZOR X SYSTEM | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MAZOR ROBOTICS LTD | TPL0059 | 07290109180465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |