{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "225123050", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T4-S2 CASE WITH THREE SEGMENTS, RIGHT T4 - T9 SCREWS WERE MEDIAL TO PLAN. THIS OCCURRED DURING THE FINAL SEGMENT WITH THE CLAMP PLACED AT T10. THE MANUFACTURER REPRESENTATIVE BELIEVED THE DEVIATIONS WERE DUE TO SKIVING AS THE SURGEON WAS ON THE RIGHT SIDE AND MALLEATING VERY HARD. THE SCREWS WERE DEVIATED LESS THAN 3.5 MM. THE SURGEON WAS NOT WORRIED ABOUT MISPLACED SCREWS DURING THE PROCEDURE SINCE ALL INTRA-OP AP IMAGES APPEARED WITHIN NORMAL LIMITS. AFTER THE PROCEDURE IN POST-OPERATION, THE PATIENT COMPLAINT OF PAIN. A POST-OP CT REVEALED T4-T9 WAS DEVIATED ON THE RIGHT SIDE. THE PATIENT WAS TAKEN BACK TO THE OR TO REPOSITION THE SCREWS WITH NAVIGATION. THERE WERE NO FURTHER SYMPTOMS AFTER THE REVISION." }, { "mdr_text_key": "322172434", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EVALUATION OF THE RETURNED SOFTWARE EXPORTS INDICATED THAT THE ROOT CAUSE OF THE DEVIATIONS TO BE IMPROPER FIXATION LOCATION, CAUSED BY NOT FOLLOWING THE SURGICAL TECHNIQUE PROTOCOL. THE CLAMP WAS POSITIONED AT T10 SPINOUS PROCESS, ALLOWING SAFE OPERATIONAL RANGE OF UP TO 2 VERTEBRAS ABOVE/BELOW THE CLAMP. ADDING THE FACT THAT THE ROBOTIC ARM WAS SENT FIRST TO THE FAR MOST T4 VERTEBRA TRAJECTORY, CAN CONTRIBUTE TO THE INSTABILITY EFFECT AND A POSSIBLE SHIFT/DEVIATION MEDIALLY OF THE SYSTEM FOR THE REST OF THE TRAJECTORIES IN THE SEGMENT. 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." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/07/2021" } ] }