Mazor X System- Refurbished TPL0059-08RRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07290109184524), received between Apr 18, 2023 and Mar 4, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K203005); they may or may not involve this specific model.

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.

Recalls naming this device

1. Dec 10, 2025Open, Classified

   Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

   Z-1122-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING AN L2 TO PELVIS CASE, THEY DID PELVIC SCREWS FIRST. THEN THEY SENT TO L2 RIGHT SIDE AND NOTED THE ARM WAS 5 MILLIMETERS (MM) INACCURATE. WHEN SURGEON WAS REMOVING THE DRILL AFTER PELVIC SCREWS, THE DRILL HAD SOME DIFFICULTY BEING REMOVED FROM THE ARM GUIDE. THEY DID NOT CHECK ACCURACY WITH PROBE, SURGEON OPTED TO RE-REGISTER. AFTER RE-REGISTERING, NOT FURTHER INACCURACIES NOTED. THERE WAS A 5-10 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507169 ↗
• MalfunctionDec 29, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE RUNNING TEST CASES WITH THE SYSTEM, IT UNEXPECTEDLY WENT UNRESPONSIVE AND RESTARTED 9 TIMES. EACH RESTART OCCURRED AT THE END OF THE ARM SETUP. THE SOFTWARE WOULD GO UNRESPONSIVE, THE SCREENS WOULD GO BLACK, AND THEN AFTER ABOUT 20-30 SECONDS IT WOULD COME BACK ON TO THE SETUP SCREEN AGAIN. ABOUT 3 TIMES, THE SCREENS REMAINED BLACK FOR ABOUT ONE MINUTE AND KICKED HER OUT TO THE MAIN LOGIN SCREEN AND HAD CLEARED ALL OF THE COMPLETED SETUP PROCESS. AFTER THE FIRST 8 TIMES IT OCCURRED, THE MANUFACTURING REPRESENTATIVE (REP) SHUTDOWN THE SYSTEM AND LEFT IT OFF FOR ABOUT TWO HOURS, AND WHEN THE REP CAME BACK THE ISSUE PERSISTED FOR A 9TH OCCURRENCE. THE REP NOTED THAT THE HOSPITAL HAD THE SYSTEM PLUGGED INTO A RED WALL OUTLET AND HAS TWO OTHER SYSTEMS ON SITE THAT WERE FUNCTIONING IN THE WALL OUTLET. THE REP ATTEMPTED TO COMPLETE THE ARM SETUP UNDER A DEMO USER AND SURGEON USER AND THERE WAS NO DIFFERENCE. THE REP WAS UNABLE TO SUCCESSFULLY COMPLETE THE SETUP AND ALSO NOTED THAT WHEN SHE SHUTS DOWN THE SYSTEM THROUGH THE SOFTWARE, THE SCREEN IMMEDIATELY DISPLAYS 'NO S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918300 ↗
• MalfunctionDec 26, 2025Computer Software Problem; Data Problem; Computer Software Problem; Data Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THEY TRIED TO START THE CASE AGAIN TODAY AFTER THE ABORTED SCAN & PLAN CASE ON MONDAY CASE (B)(4). HOWEVER, AFTER TAKING THE SPIN FOR THE SCAN & PLAN CASE, THEY TRIED TO PUSH THE EXAM FROM THE MEDTRONIC IMAGING SYSTEM TO THE MEDTRONIC GUIDANCE SYSTEM OVER ETHERNET. SINCE THE PATIENT ATTEMPTED TO BE OPERATED ON MONDAY, THE PATIENT'S MEDICAL RECORD NUMBER (MRN) FROM THEN ALREADY EXISTED IN THE SYSTEM. THE SYSTEM ASKED IF THEY WANTED TO COMBINE MRNS, TO WHICH THEY SAID YES. HOWEVER, THE PROGRESS BAR FOR THE TRANSFER WAS STUCK AT 0% FOR A FEW SECONDS BEFORE THEY HALTED THAT ATTEMPT. THE EXAM WAS EXPORTED FROM THE IMAGING SYSTEM TO A UNIVERSAL SERIAL BUS (USB) AND TRIED TO IMPORT IT THAT WAY, BUT THE PROGRESS BAR FOR LOADING THAT EXAM WAS STILL STUCK ON 0%. THEY WAITED FOR ABOUT 4 MINUTES BEFORE THEY HALTED IT AND PERFORMED A SOFTWARE REBOOT. THE SOFTWARE REBOOT REQUIRED THEM TO MOVE THE ROBOT ARM, AND WITHOUT A SUCCESSFUL TRANSFER OF THE EXAM FROM THE IMAGING SYSTEM, THEY WOULD HAVE TO PERFORM ANOTHER SPIN OF THE PATIENT TO TRY TRANSFERRING THE IMAGE AGAIN. HOWEVER, DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898907 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT "PIF" FROM LEVELS T11-PELVIS ON 7/31. THE PATIENT WAS FOUND TO HAVE PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND UNDERWENT SURGERY TO REVERSE THIS. THE PATIENT WAS IMPROVING FOLLOWING INDEX THE SURGERY, BUT DEVELOPED MID BACK PAIN ALONG THE PROXIMAL ASPECT OF THE THORACOLUMBAR FUSION, WHICH WAS DIFFERENT FROM THE PATIENT'S PREOPERATIVE PAIN. THE PATIENT DENIED ANY LOWER EXTREMITY PAIN, PARESTHESIA, OR WEAKNESS, SADDLE PARESTHESIA OR BOWEL/BLADDER INCONTINENCE. ON IMAGING, THE PATIENT WAS FOUND TO HAVE A BURST FRACTURE OF T11 VERTEBRAE WITH PJK AT T10-11. THE PATIENT THEN UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, MEDICATION REFILLS, AND SUBSEQUENTLY AN EXTENSION FROM THEIR FUSION FROM T4-T1. THORACIC KYPHOSIS MEASURED AT 76 DEGREES, LUMBAR LORDOSIS MEASURED 59 DEGREES, PELVIC INCIDENCE MEASURED TO THE 70S, AND PELVIC TILT MEASURED AT 35 DEGREES. THE BILATERAL POSTERIOR INSTRUMENTED SCREW AND ROD FIXATION WAS PRESENT FROM T11 TO THE PELVIS. THE METALLIC INTERBODY DEVICES WERE PRESENT AT L4-5, L5-6, L6-S1 WITH ANTERIOR PLATE FIXATION AT L6-S1.

  Patient problems: Pain; Spinal deformity

  MAUDE report 23686586 ↗
• InjuryOct 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. IT WAS STATED THAT DURING NAVIGATION, THE TRAJECTORIES APPEARED TO BE ACCURATE, BUT AFTER PLACING T4 SCREW ON THE RIGHT SIDE, THE SURGEON WAS NOTIFIED BY NEURO-MONITORING TEAM THAT THEY HAD LOST READINGS OF THE PATIENT'S RIGHT LEG. AFTER TAKING AN IMAGE TO CONFIRM SCREW PLACEMENT, THE SCREW APPEARED TO BE PLACED MEDIALLY BY AN UNKNOWN AMOUNT OF UNITS. THEY TOOK OUT THIS SCREW AND ABANDONED USE OF THE ROBOT AND CLOSED THE PATIENT. THEY RE-PLACED THIS SCREW USING THE MEDTRONIC NAVIGATION SYSTEM DURING A FOLLOW UP SURGERY ON (B)(6) 2025. THE PATIENT WAS BEING MONITORED FOR PARALYSIS ON THE RIGHT LEG. SURGICAL DELAY WAS NOTED AS 5-10 MINUTES. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SITE REGISTERED ONCE, BUT THE C-ARM BUMPED THE ROBOT ON THE WAY OUT, SO THEY HAD TO REGISTER A SECOND TIME. IT WAS ALSO NOTED THAT THE PLANNED TRAJECTORY AT T4 ON THE RIGHT, WAS ORIGINALLY WITHIN THE PREFERRED PARAMETERS FOR AN OPEN CASE, HOWEVER, UPON DRILLING AT THE ORIGINAL TRAJECTORY THE DOCTOR FELT THEY WERE TO

  Patient problems: Paralysis

  MAUDE report 23385588 ↗
• MalfunctionFeb 19, 2025Imprecision; Use of Device Problem; Imprecision; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION ACCURACY LOOKED DEEP BY A FEW MILLIMETERS. THEY RETOOK A SNAPSHOT AND THE ACCURACY WAS STILL OFF. THE SURGEON WAS ABLE TO PLACE ALL THE SCREWS WITHOUT ISSUE. IT WAS ALSO REPORTED THAT THEY RAN INTO REGISTRATION ISSUES. THE EXAM QUALITY WAS GOOD. THEY REGISTERED OFF OF L5. THE RED MARKER WAS ABOUT 2 CM POSTERIOR TO WHERE IT WAS IN THE PLAN. THE MANUFACTURER REPRESENTATIVE REGISTERED OFF OF L4 USING ADVANCED REGISTRATION AND WAS ABLE TO GET IT TO PASS. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE DUE TO THESE ISSUES. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410195 ↗
• MalfunctionFeb 18, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING THE CASE. THE SURGEON FOUND THE TRAJECTORY WAS 2 INCHES ANTERIOR AND 1-2 INCHES SUPERIOR FROM THE TARGET LOCATION. THE FIRST SPIN WAS LOW DOSE SO A SECOND HIGH DOSE SPIN WAS DONE. THE SCAN WAS USED AND THE SCREWS WERE PLANNED. THE SURGICAL ARM WAS SENT TO ALL TRAJECTORIES. THE SURGEON THEN MADE A STAB INCISION AND THEN FOUND THE INACCURACY. THE C-ARM AS BROUGHT IN THE TRAJECTORY WAS IN THE DISC SPACE ABOVE THE VERTEBRAL BODY. THE SURGICAL SYSTEM WAS CHECKED AND A NEW SNAPSHOT WAS DONE, BUT THE TRAJECTORY WAS STILL INACCURATE. A NEW SPIN WAS TAKEN AND THERE WERE NO FURTHER ISSUES. THE SCREWS WERE PLACED ACCURATELY. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402746 ↗
• MalfunctionFeb 13, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS WERE INACCURATE BY ABOUT 5 TO 6 MM DURING A CASE. THE HEALTHCARE PROFESSIONAL WENT BACK TO REVERIFY ALL OF THE INSTRUMENTS. AFTER THE VERIFICATION, THE INSTRUMENTS SEEMED ON, BUT ONCE THEY RETURNED TO NAVIGATION, THEY WERE OFF AGAIN. THE SURGEON RELUCTANTLY CONTINUED SURGERY, BUT THE DELAY WAS APPROXIMATELY TWO HOURS. THE ONLY INSTRUMENT THAT WAS ACCURATE IN THE CASE WAS THE DRILL. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SITE RE-REGISTERED TO RESOLVE THE INACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376451 ↗
• MalfunctionFeb 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE MIDAS SEEMED TO BE INACCURATE DURING A L5-S1 FUSION. THE MIDAS WAS INACCURATE (SUPERIOR AND LATERAL BY AN UNKNOWN METRIC) ON RIGHT SIDE L5. THE SITE PROCEEDED WITH THE CASE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. THERE WAS TROUBLESHOOTING PRESENT. THE NAVLOCK WAS REPOSITIONED AND REVERIFIED AND IT WAS CONFIRMED ALL OTHER INSTRUMENTS WERE ACCURATE. THE POST-SPIN REVEALED ALL SCREWS WERE ACCURATE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY SEEN WAS AROUND 3 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355886 ↗
• MalfunctionFeb 4, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A SCREW DEVIATION THAT OCCURRED DURING AN L5-S1, SINGLE LEVEL. THE PATIENT WAS REGISTERED WITHOUT ISSUE, THE SITE HAD PLACED INTERBODY THE PREVIOUS HOUR DURING OLIF, PROCEEDED WITH S1 SCREWS WITHOUT ISSUE, AND NAVIGATION LOOKED ACCURATE. THE L5 SCREW WAS GOING TO BE PLACED NEXT ON THE RIGHT. IT WAS DRILLED AND THE SITE ATTEMPTED TO TAP, BUT THE TAP WAS NOT SITTING DOWN TO FIND THE PILOT HOLE, EVEN THOUGH NAVIGATION APPEARED ACCURATE. THE SITE USED A C-ARM TO TAKE A SHOT AND DISCOVERED THE TRAJECTORY TO BE 1CM LOW. THE SITE CHECKED NAVIGATION, AND SUSPECT A PATIENT SHIFT OR FRAME SHIFT. THIS WAS CONFIRMED WITH A C-ARM FOR S1 SCREWS, WHICH WAS 1CM LOW AS WELL. S1 SCREWS WERE REMOVED. THE SITE RE-REGISTERED, SENT BACK TO TRAJECTORY, AND ALTERED S1 PLAN SCREWS TO BRING MORE SUPERIOR. THE SCREWS WERE PLACED, AND CONFIRMED ACCURATE WITH THE C-ARM. THE SITE PROCEEDED TO THE L5 SCREWS, WHICH WERE ALSO ACCURATE. THE ISSUES EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307020 ↗
• MalfunctionJan 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE TWO SCREWS THAT WERE FOUND MEDIAL, ONE AT LEFT L4 AND RIGHT T11. BOTH OF THE SCREWS WERE REPOSITIONED WITH NAVIGATION AFTER THE GUIDANCE SYSTEM WAS FINISHED. IT SEEMED THE TISSUE PRESSURE FACTORED IN AS THE SITE WAS FIGHTING IT WHEN PLACING L4 WITH A CANNULA. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210866 ↗
• MalfunctionJan 14, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A LUMBAR FRACTURE CASE, THEY EXPERIENCED AN ACCURACY ISSUE WHERE THE SCREW WAS PLACED MEDIALLY BY 3.5-10 MM. THE NAVIGATION SYSTEM AND PUT THE REST OF THE SCREWS IN. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THERE WAS NO KNOWN IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149169 ↗
• MalfunctionJan 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CASE WAS CONTINUED WITH NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127144 ↗
• InjuryOct 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS 1-2 MM OFF ON THE CERVICAL. IT WAS THE RIGHT C4 THAT THE DOCTOR FELT INACCURATE. THE PATIENT LOST BLOOD (500CC'S). BLEEDING WAS ABLE TO BE CONTROLLED. THE PROCEDURE WAS DELAYED 10 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20369175 ↗
• MalfunctionSep 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT SECOND TRAJECTORY NAVIGATION APPEARED TO BE A COUPLE OF INCHES OFF. IT WAS REPORTED THAT NAVIGATION WAS TOTALLY ACCURATE WHEN CHECKING IN THE DIVOT. THEY RE-VERIFIED AND THEN THE SYSTEM STARTED TO BECOME UNRESPONSIVE AND STOPPED WORKING. THE SYSTEM WAS REBOOTED AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AD SURGICAL DELAY WAS REPORTED AS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE NAVIGATION DEVIATION WAS BY 2CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246874 ↗
• MalfunctionJul 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT AFTER TAKING CONFIRMATION IMAGES WITH THE NON-MEDTRONIC IMAGING SYSTEM, THE SURGEON NOTICED THAT 3 OF THE 4 SCREWS PLACED HAD DEVIATED FROM THE PLAN. THE SURGEON DECIDED 1 DEVIATED SCREW WAS ACCEPTABLE, BUT THE OTHER 2 NEEDED TO BE REPOSITIONED. THE LEFT L3 SCREW DEVIATED LATERALLY BY 3-4 MILLIMETERS (MM) AND THE RIGHT L3 SCREW DEVIATED MEDIALLY BY 3-4 MM. TO REPOSITION THESE SCREWS THE SURGEON SWITCHED TO MEDTRONIC IMAGING AND NAVIGATION SYSTEMS. IT WAS REPORTED THIS OCCURRED ON A LOANER SYSTEM. THE PROBABLE CAUSE NOTED WAS A POSSIBLE SOFTWARE ISSUE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS REPORTED AS LESS THAN ONE-HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750783 ↗
• MalfunctionDec 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD A QUESTIONABLE SCAN IN WHICH THE RE PRESENTATIVE RECOMMENDED TO NOT PROCEED WITH THE CASE, HOWEVER, THE SURGEON ASKED THAT THEY STILL TRY. THEY PROCEEDED TO REGISTER AND GOT GREEN VALUES. IT WAS NOTED THEY WERE DILIGENT IN SCROLLING THROUGH THE LEVEL VERIFICATION AND DID NOT NOTATE ANY SHIFT. NOTHING SEEMED AMISS THROUGHOUT THE CASE. HOWEVER, WHEN THEY TOOK THE FINAL XRAY, IT WAS NOTICED ALL SCREWS HAD DEVIATED AND WERE NOT TO PLAN WHICH CAUSED A TEAR IN THE DURAL. SCREWS WERE REDIRECTED MANUALLY WITH FLOURO AND NAVIGATION WAS ABORTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THAT THE PROCEDURE PERFORMED WAS A L4-S1 POSTERIOR SPINAL FUSION USING OPEN SOLERA IN WHICH THE ISSUE OCCURRED INTRAOPERATIVELY. THERE WAS A 45 MINUTE DELAY TO THE CASE AS THE SCREWS WERE RE-DIRECTED UNDER FLOURO AND THE PATIENT EXPERIENCED NO NEGATIVE SIDE EFFECTS. THE PATIENT WAS REPORTED TO BE "FINE" AND NEUROLOGICALLY INTACT. THE AMOUNT OF DEVIATION WAS REPORTED TO HAVE BEEN BETWEEN 3.5 AND 10 MILLIMETERS (MM).

  Patient problems: Spinal Cord Injury

  MAUDE report 18410589 ↗
• MalfunctionApr 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE HOOD OF THE SYSTEM DROPS AND LOSES PRESSURE, AND THE SURGICAL SYSTEM LOST PRESSURE AS WELL, IT WOULD NOT STAY UP. ALSO, THE MANUFACTURER REPRESENTATIVE WAS HAVING TROUBLE CALIBRATING THE ARM. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203005. One submission often covers many models, so check the product and lot details in each record.

• Z-0101-2024 · Sep 5, 2023 · Open, Classified
  MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1