Renaissance System TPL0038-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07290109180267), received between Oct 7, 2017 and Feb 24, 2025 — classified as 1 death, 16 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Imprecision” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT L3 RIGHT WAS MISPLACED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TRAJECTORIES AT L3 RIGHT WERE DEVIATED LESS THAN 2 MM. THERE WAS ABOUT A 10-15 MINUTE DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THE CAUSE OR POTENTIAL CONTRIBUTING FACTORS OF THE DEVIATION WERE STATED TO BE DUE TO OPERATING ON AN INSTABLE BONY SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448200 ↗
• MalfunctionFeb 24, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT THE L5 LEFT SCREW WAS DEVIATED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED BY ABOUT TEN MINUTES. THE TRAJECTORY WAS DEVIATED BY ABOUT ONE TO TWO MILLIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447914 ↗
• MalfunctionFeb 24, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT 6/6 SCREWS WERE MISPLACED. THE CASE WAS ABORTED DUE TO THE ISSUE WITH THE SYSTEM'S FUNCTIONALITY. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447726 ↗
• MalfunctionFeb 24, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE ON L1 TO L5 TO ADDRESS SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE PROCEDURE WAS A REVISION AND WAS COMPLETED IN ONE SEGMENT. A CLAMP WAS SECURED TO L1, ONE AP AND ONE OBLIQUE IMAGE WAS TAKEN. TEN SCREWS WERE PLANNED, BUT ONLY TWO WERE CLINICALLY REQUIRED. THE TWO SCREWS WERE EXECUTED. THE LEFT L1 WAS ACCURATE, BUT THE RIGHT L1 WAS DEVIATED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO PATIENT SYMPTOMS WERE EXPERIENCED DUE TO THIS ISSUE. THERE WAS NO DELAY TO THE PROCEDURE AND TRAJECTORIES WERE DEVIATED LESS THAN 2MM. THE CAUSE OR SUSPECTED CAUSE OF THE ISSUE WAS STATED TO BE MAYBE DUE TO THE PLAN AND DRILLING ON A SLOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446625 ↗
• MalfunctionFeb 24, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT T12L WAS DEVIATED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE DEVIATION WAS LESS THAN 2MM. THE SUSPECTED OR MOST LIKELY CAUSE WAS THE CASE BEING PLANNED AND EXECUTED ON AN UNSTABLE SURFACE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED BY ABOUT 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446387 ↗
• MalfunctionFeb 19, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER CALIBRATION, THE GUIDANCE SYSTEM WAS TESTED FOR ACCURACY. THE RESULTING TARGET WAS DEVIATED FROM THE ORIGINAL REGISTERED TARGET BUT WAS STILL WITHIN RANGE. FOR PRECAUTIONARY REASONS, THE GUIDANCE SYSTEM WOULD BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411015 ↗
• MalfunctionFeb 19, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ONE AP AND ONE OBLIQUE IMAGE WERE TAKEN. A HOVER-T MOUNT WAS SECURED TO L4 FOR STABILITY. EIGHT SCREWS WERE PLANNED, BUT ONLY FOUR SCREWS WERE CLINICALLY REQUIRED. THE FOUR SCREWS WERE EXECUTED ON L2 AND L5. THE RIGHT L5 SCREW WAS MISPLACED, SO THE TRAJECTORY WAS RE-EXECUTED ACCURATELY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO PATIENT SYMPTOMS DUE TO THE ISSUE. THE PROCEDURE WAS DELAYED 10-15 MINUTES DUE TO THE ISSUE. THE TRAJECTORIES WERE DEVIATED LESS THAN 2MM. THE CAUSE OR SUSPECTED CAUSE OF THE ISSUE WAS STATED TO BE MAYBE DUE TO THE DRILL ON AN UNSTABLE POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410435 ↗
• InjuryAug 23, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE ON L4-L5 TO ADDRESS SPONDYLOLISTHESIS. IT WAS REPORTED THAT  A CLAMP WAS FIXED TO L5, AND SIX AP AND OBLIQUE IMAGES WERE TAKEN. THE SEGMENTATION DID NOT SUCCEED ON THE FIRST TRY. THE SCREWS WERE NOT EXECUTED DUE TO REGISTRATION FAILURE. THE CLINICAL CASE WAS ABORTED DUE TO SYSTEM FUNCTIONALITY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276506 ↗
• MalfunctionAug 11, 2021Imprecision; Mechanical Problem; Imprecision; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION WAS DUE TO THE BASE BEING REINFORCED DUE TO LOOSE SCREWS. THE SCREWS HAD MISSING THREADS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12308056 ↗
• MalfunctionJun 3, 2021Imprecision; Imprecision

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT TROUBLESHOOTING INVOLVED RE-REGISTERING THE PATIENT, REMOUNTING THE SURGICAL SYSTEM AND CHECKING FOR SHIFTS. THE TRAJECTORIES WERE DEVIATED BETWEEN 3-5 MM. THE CASE WAS COMPLETED AND THE SURGEON DECIDED TO LEAVE THE SCREWS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935843 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING RENAISSANCE SYSTEM SURGERY ((B)(6) 2018, (B)(6) HOSPITAL), POSTERIOR ROBOTIC SCREWS WERE PLACED (PRONE POSITION) AT L3/L4/L5. LEFT SCREW WAS DEVIATED MEDIALLY. THEREAFTER, THE PATIENT HAD A LEG PAIN AND A REVISION CASE WAS PERFORMED IN ORDER TO CORRECT THE DEVIATED ISSUE. IT WAS NOTED DURING THE CASE THAT THE L5 SCREWS ON BOTH SIDES HAD TISSUE PRESSURE WHICH MIGHT HAVE PUSHED THE ROBOTIC INSTRUMENTATION MEDIALLY, AS THE EXPOSURE OR THE INCISION WAS NOT EXTENDED TO ACCOMMODATE THE LATERAL ANGLE OF THE SCREWS. ACCORDING TO THE CLINICAL DOCUMENTATION, NO DEVICE MALFUNCTION OCCURRED DURING THE SURGERY.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8188537 ↗
• InjuryNov 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT (B)(6), BACK ON (B)(6) 2016, THE CUSTOMER CALLED AND REPORTED (ON (B)(6) 2018) THAT THE PATIENT IS SUING THE CLINIC BECAUSE OF WOUND HEALING ISSUES (WOUND INFECTION) AFTER A RENAISSANCE CASE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016, FOR DECOMPRESSION OF L3-L4 AND SPONDYLODESIS WITH CAGE L4-L5. THE SPONDYLODESIS WAS PERFORMED WITH THE RENAISSANCE SYSTEM, KIT CODE USED: CQDAVSV. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WENT THROUGH A REVISION SURGERY. POST OPERATIVE THE L5 LEFT SCREW WAS LOOSENED AND THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2016 USING THE RENAISSANCE SYSTEM, KIT CODE USED:CKBSM8X. THE PATIENT DEVELOPED WOUND HEALING DISORDER. THE RBT DEVICE (I.E., GUIDING UNIT) STERILE COVER STERILITY ASSURANCE WAS VERIFIED, AND NO DEFICIENCIES IN THE STERILIZATION OF THE SPECIFIC LOTS WERE IDENTIFIED. THIS EVENT WAS DETERMINED TO BE REPORTABLE THOUGH, DUE TO THE REVISION SURGERY THE PATIENT HAD TO GO THROUGH.

  Patient problems: Iatrogenic Source

  MAUDE report 8082388 ↗
• InjuryNov 5, 2018Unintended Movement; Unintended Movement

  FOLLOWING A SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT (B)(6) HOSPITAL, BACK ON (B)(6) 2016, THE CUSTOMER ALLEGED (ON (B)(6) 2018) THAT T2 & T3 RIGHT TRAJECTORIES WERE MEDIAL AND THAT THIS LEAD TO A REVISION SURGERY.

  Patient problems: Iatrogenic Source

  MAUDE report 8036738 ↗
• MalfunctionOct 24, 2018Mechanics Altered; Unintended Movement; Mechanics Altered; Unintended Movement

  DURING A BRAIN SURGERY WITH THE RENAISSANCE SYSTEM ON (B)(6) 2014 AT (B)(6), THERE WAS A MOVEMENT OF THE UPPER PART OF THE RENAISSANCE RBT DEVICE (I.E., (B)(4) CAROUSEL). THE CASE WAS PLANNED AS A DEEP BRAIN STIMULATION PROCEDURE WITH BILATERAL TRAJECTORIES (LEFT AND RIGHT SUB THALAMIC NUCLEUS) FOR MOTION DISORDERS / PARKINSON'S DISEASE. THE PRODUCT WAS MOUNTED TO THE PATIENT IN ACCORDANCE WITH THE RENAISSANCE SURGICAL TECHNIQUE. THREE CANNULAS AND ELECTRODES (THIRD PARTY MANUFACTURER) WERE INSERTED INTO THE PATIENT'S BRAIN. WHILE THE PRODUCT WAS MOUNTED TO THE PATIENT AND IN A LOCKED POSITION, THERE WAS A MOVEMENT - A ROTATIONAL SHIFT IN THE RBT CAROUSEL. THE CAROUSEL IS A ROTATIONAL PLATFORM. IT HAS 18 DISCRETE STATIONS, AND THERE IS A PIN PRESSED BY A SPRING THAT LOCKS THE PLATFORM IN STATION. THE ISSUE WAS MALFUNCTIONING OF THE MECHANISM THAT LOCKS THE CAROUSEL IN A SPECIFIC STATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001805 ↗
• MalfunctionOct 21, 2018Material Puncture/Hole; Material Puncture/Hole

  THE REPORTED EVENT IS RELATED TO A PROCEDURE THAT WAS PERFORMED AT 'DESERT REGIONAL MEDICAL CENTER', CALIFORNIA US, ON (B)(6) 2016. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO COMPLICATIONS. FURTHERMORE, THE REPORT MENTIONED THAT THE STERILE COVER FOR THE RBT DEVICE FROM THE DISPOSABLE KIT HAD A HOLE IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988361 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO DATA THAT WAS GATHERED AS PART OF AN ONGOING PROSPECTIVE CLINICAL STUDY (PMCF), THREE ADVERSE EVENTS WERE REPORTED WITH THE FOLLOWING ISSUES: ONE PATIENT SUFFERED FROM RIGHT LOWER EXTREMITY RADICULOPATHY. A REVISION SURGERY WAS PERFORMED. ONE PATIENT SUFFERED FROM LEFT FOOT DROP, REQUIRING CONSERVATIVE TREATMENT AND/OR MEDICATION. ONE PATIENT SUFFERED FROM PSEUDOARTHROSIS. ONLY THE SECOND EVENT RESULTED IN A PERMANENT DAMAGE OR DISABILITY. THE TWO OTHER EVENTS WERE RESOLVED.

  Patient problems: Neurological Deficit/Dysfunction; Spinal Column Injury

  MAUDE report 7988292 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED EVENT IS RELATED TO A L4-S1 PROCEDURE THAT WAS PERFORMED AT (B)(6) US, ON (B)(6) 2016. THE PATIENT SUFFERED FROM DEGENERATIVE DISC DISEASE AND A PROCEDURE WAS PERFORMED IN L4-S1 SUCCESSFULLY ALL SCREWS WERE FOUND TO BE ACCURATE. HOWEVER, IT WAS REPORTED THAT S1 LEFT TRAJECTORY SEEMED TO BE LOW IN COMPARISON TO THE PLAN. FURTHER INFORMATION REGARDING THIS EVENT EXPLAINED THAT THE SURGEON DID NOT TAKE CONFIRMATORY IMAGES UNTIL THE K-WIRE WAS PLACED. FURTHERMORE, WHEN PASSING THE ROD ON THE LEFT SIDE, THE SURGEON ENCOUNTERED HIGH RESISTANCE. CONSEQUENTLY, THE ROD HIT THE SACRUM. FEW DAYS AFTER, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SOME LEG PAIN AND MOTOR DEFICIT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7988260 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED EVENT IS RELATED TO A L4-L5 PROCEDURE THAT WAS PERFORMED AT (B)(6) MEDICAL CENTER', US, ON (B)(6) 2016. DURING THE PROCEDURE, UPON SENDING THE RBT TO L4 LEFT TRAJECTORY, THE SURGEON DID NOT CHANGE THE RBT DEVICE'S STATION ON THE PLATFORM ACCORDING TO THE SOFTWARE INSTRUCTIONS. THEREFORE, THE TRAJECTORY WAS DRILLED FROM THE WRONG STATION WHICH LED TO INACCURACY. CONSEQUENTLY, THE SURGEON DRILLED L4 LEFT TRAJECTORY INSIDE THE DISC SPACE. FLOURO SHOT CONFIRMED THE REPORTED FINDING. SURGEON INCREASED DISSECTION AND USED BOVIE TO CONTAIN THE BLEEDING. DUE TO DROP IN BLOOD PRESSURE THE SURGEON CALLED IN A VASCULAR SURGEON. FINALLY, THE CASE WAS ABORTED DUE TO AN EXCESSIVE DROP IN BLOOD PRESSURE AND THE PATIENT WAS BROUGHT BACK TO COMPLETE THE SURGERY THE FOLLOWING DAY. THE PROCEDURE WAS PERFORMED WITH THE RENAISSANCE SYSTEM SUCCESSFULLY WITH NO FURTHER COMPLICATIONS. THERE WAS NO RESIDUAL DAMAGE TO THE PATIENT FROM THE INCIDENT.

  Patient problems: Blood Loss; Disc Impingement

  MAUDE report 7988255 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING TWO DBS ELECTRODE PLACEMENT PROCEDURES USING THE RENAISSANCE SYSTEM ON (B)(6) 2016 AT (B)(6), TWO PATIENTS SUFFERED FROM INFECTION AT THE BURR HOLE SITE. THIS EVENT WAS REPORTED TO MAZOR THREE WEEKS LATER, ON (B)(6) 2016.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 7988187 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T1-T5 CASE DONE AT (B)(6) ON (B)(6) 2016 WITH ALL SCREWS LOOKING ACCURATE. ON (B)(6) THE SURGEON REVISED THE LEFT T4 AND T5 SCREWS.

  Patient problems: Iatrogenic Source

  MAUDE report 7988008 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT (B)(6), ON (B)(6) 2018 (REPORTED TO MAZOR ON SEPTEMBER 03, 2018) WE RECEIVED THE FOLLOWING REPORT FROM A SENIOR SURGEON (VERBATIM): "ON (B)(6), DURING A TRAUMA CASE AT 21:00, THE OPERATING SURGEON HAS HAD 1 LATERAL SCREW AND 1 MEDIAL SCREW AT T11. THE REASON, ACCORDING TO THE SENIOR SURGEON, IS THAT THE OPERATING SURGEON USED THE HOVER-T PLATFORM, BUT CHOSE THE MDB ICON ON THE OPERATION MODE, AND ON T11 WHEN THE SW SUGGESTED A SOLUTION WITH SLIDER STATIONS OTHER THAN CENTER, HE DID NOT REALIZE THAT, AND PROCEEDED WITH SLIDER STATION 21, WHILE IN FACT HE WAS USING THE HOVER-T MEANING THERE IS NO OPTION FOR MOVING THE SLIDER. THIS HAS RESULTED IN 1 LATERAL AND 1 MEDIAL DEVIATION IN T11. AFTERWARDS THE SURGEON HAS NOTICED THE ERROR AND CHOSE CENTER FOR ALL TRAJECTORIES. THE SURGEON HAS CHOSEN MDB AND PROCEEDED WITH THE SOLUTION WITH SLIDER STATIONS, WHILE IN FACT HE MOUNTED THE HOVER-T PLATFORM. THE SURGEON HAS STATED THE PATIENT IS SUFFERING FROM A SEVERE NEURAL DEFICIT, THE PATIENT CAN BARELY MOVE HIS LEGS." A FOLLOW UP REPORT FROM MAZOR CLINICAL SALES REPRESENTATIVE SUPPORTING THE SITE A WEEK LATER: "THE PATIENT WAS ABLE TO

  Patient problems: Muscle Weakness/Atrophy; Nerve Damage; Neurological Deficit/Dysfunction; Paresis; Spinal Column Injury

  MAUDE report 7914217 ↗
• DeathJul 19, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2018 AT (B)(6) PRIVATE HOSPITAL ((B)(6)) A (B)(6) FEMALE PATIENT WAS OPERATED ON HER L4 VERTEBRA. THE SURGICAL PLAN WAS TO PLACE BILATERAL PEDICLE SCREWS (45 X 6.5 MM, EVEREST XT, K2M) IN L4 AS AN EXTENSION OF A PREVIOUS L5-S1 FUSION SURGERY. AS THE LEFT L4 PEDICLE SCREW WAS BEING IMPLANTED, THE ANAESTHETIST MADE THE SURGEON AWARE THAT THERE WAS A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE. A LATERAL X-RAY IMAGE WAS TAKEN OF THE SCREWS, WHICH SHOWED THAT THE FRONT OF THE RIGHT L4 SCREW WAS PROTRUDING OUT OF THE FRONT OF THE L4 VERTEBRAL BODY. AT THIS POINT, THE ROBOTIC PLATFORM AND THE RIGHT L4 PEDICLE SCREW WAS IMMEDIATELY REMOVED. THE LEFT L4 PEDICLE SCREW REMAINED IN SITU. THE PATIENT WAS CLOSED UP POSTERIORLY AND HANDED OVER TO THE VASCULAR SURGEONS. THE PATIENT PASSED AWAY LATER THAT DAY.

  Patient problems: Death

  MAUDE report 7704414 ↗
• MalfunctionJul 1, 2018Use of Device Problem; Use of Device Problem

  DURING A SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT CORNERSTONE SURGERY CENTER (USA) ) ON (B)(6) 2018, THE REGISTRATION PROCESS WAS CHALLENGING AND REQUIRED MULTIPLE ATTEMPTS. WHILE GUIDING UNIT AND PLATFORM WERE CONNECTED TO THE PATIENT, THE PATIENT BUCKED AND MOVED CAUSING THE ENTIRE PLATFORM TO MOVE REQUIRING REREGISTRATION. AFTER COMPLETION OF ANOTHER REGISTRATION IT WAS NOTICED THAT THE GUIDING UNIT WAS BROKEN BY THE PATIENT'S MOVEMENT AND THE SURGEON DECIDED TO ABORT THE SURGERY AND CONTINUE FREE HAND. NO PATIENT HARM REPORTED. TRYING TO TROUBLESHOOT THE REGISTRATION ISSUES RESULTED IN A PROLONGATION OF SURGERY BY OVER AN HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7653973 ↗
• InjuryJun 10, 2018Use of Device Problem; Use of Device Problem

  DURING A SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT (B)(6) (USA) ON (B)(6) 2018, THE REGISTRATION PROCESS FAILED. TRYING TO TROUBLESHOOT THE REGISTRATION ISSUES RESULTED IN A PROLONGATION OF SURGERY BY OVER AN HOUR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7585410 ↗
• InjuryMay 27, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, AT (B)(6) THE SURGEON ATTEMPTED TO USE THE RENAISSANCE SYSTEM IN A L5-S1 SPINAL FUSION SURGERY. REGISTRATION WAS ATTEMPTED SEVERAL TIMES BUT FAILED BECAUSE THE CT OF THE PATIENT WAS NOT ACCORDING TO MAZOR'S PROTOCOL. THE SURGEON REVERTED TO A SCAN-AND-PLAN REGISTRATION. WHEN ATTEMPTING TO INSTRUMENT THE ANATOMY, THERE WERE REACHABILITY ISSUES AND "THE SURGEON DECIDED IT WAS BEST TO ABORT THE CASE AND PLAN TO COME BACK ANOTHER DAY." IT WAS SINCE REPORTED THAT THE PATIENT IS FINE AND THE SURGERY WILL BE RESCHEDULED FOR A LATER DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547211 ↗