7D Surgical System 10-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00628341520379), received between Feb 25, 2020 and Mar 24, 2026 — classified as 2 deaths, 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Detachment of Device or Device Component

  ON 23 FEB 2026, ORTHOFIX RECEIVED AN ARTICLE WHICH STATES THAT AT FIVE WEEKS POSTOPERATIVELY, THE PATIENT DEVELOPED PROGRESSIVE RIGHT ARM PAIN AND WEAKNESS. CT/MRI IMAGING FOUND BILATERAL C2 LAMINAR FRACTURES WITH SCREW LOOSENING AND CORD IMPINGEMENT. AS A RESULT, THE PATIENT UNDERWENT A REVISION SURGERY WITH SCREW REMOVAL AND EXTENSION OF FUSION DOWN TO C4. AFTER 5 WEEKS OF INPATIENT REHABILITATION, HE COULD WALK WITH ASSISTANCE.

  Patient problems: Limb Pain; Muscle Weakness/Atrophy

  MAUDE report 24676576 ↗
• DeathMar 20, 2026Improper or Incorrect Procedure or Method

  ON 19 FEB 2026, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT THAT OCCURRED DURING SURGERY USING 7D SURGICAL FLASH IMAGING. PER THE REPORTER, THE SURGEON HAD DIFFICULTY ACHIEVING AN ACCURATE NAVIGATION REGISTRATION. DURING THIS TIME, A DURAL TEAR OCCURRED AND BLOOD LOSS WAS OBSERVED. AS PER REPORTER, A SPINOUS PROCESS CLAMP WAS USED AS A REFERENCE FRAME, AND THE SURGEON ELECTED TO PLACE SCREWS USING FREEHAND TECHNIQUE. INFORMATION REPORTED INDICATED THE PROCEDURE PROGRESSED TO THE THORACIC SPINE WHERE THE PREOPERATIVE PLAN WAS TO PLACE PEDICLE SCREWS AT T1-T2. DURING SURGERY, NAVIGATION REGISTRATION WAS ARCHIVED WITH ANATOMICAL POINTS CORRESPONDING TO T2 AND T3, AND INTRAOPERATIVE IMAGING CONFIRMED THAT THE SCREWS WERE PLACED AT T2-T3 AND WERE NOT REVISED. SCREWS WERE NAVIGATED AT C3-C6. INTRAOPERATIVE IMAGING IDENTIFIED SCREWS PLACED IN THE DISC SPACE. THE LEFT-SIDED SCREWS WERE REVISED. THE RIGHT-SIDED SCREWS WERE ASSESSED BY THE SURGEON AS ACCEPTABLE.

  Patient problems: Dural Tear; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24654496 ↗
• MalfunctionJan 15, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2025, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING. PER THE REPORTER, THE SURGEON PERFORMED A SEGMENTAL REGISTRATION ON L4 THEN PROCEEDED TO USE THE BALL TIP POINTER, NAVIGATED BURR, AND NAVIGATED TAP TO MAKE PILOT HOLES. A 3D C-ARM SPIN WAS PERFORMED, AND IT WAS NOTED THAT THE RIGHT L4 AND L5 PILOT HOLES WERE NOT ACCURATE AND APPEARED TO GO THROUGH THE FORAMEN. NEURO-MONITORING DID NOT REPORT ANY ISSUES. THE SURGERY WAS COMPLETED WITHOUT NAVIGATION. IT WAS REPORTED BY THE PA THAT THE SCREWS WERE PLACED IN THE SAME TRAJECTORY AS THE ORIGINAL NAVIGATED PILOT HOES. PATIENT CONDITION WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24089578 ↗
• MalfunctionOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2025, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT THAT OCCURRED DURING NAVIGATION USING THE 7D SURGICAL SYSTEM. ACCORDING TO THE REPORTER, SURGEON ACCEPTED REGISTRATION ON THE L1-2 BLOCK THAT ONLY GOT GOOD COVERAGE ON THE LEFT SIDE. THE LEFT SIDE SCREWS WERE PLACED WITHOUT ISSUE. WHEN THE SURGEON MOVED TO THE RIGHT SIDE, THE INSTRUMENT APPEARED TO BE FLOATING. SEVERAL UNSUCCESSFUL REGISTRATION ATTEMPTS WERE MADE. THE SURGEON OPTED TO PROCEED WITHOUT 7D AND SWITCHED TO AN O-ARM, RESULTING IN A DELAY OF GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303309 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15 SEP 2025, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT THAT OCCURRED DURING NAVIGATION USING THE 7D SURGICAL SYSTEM. ACCORDING TO THE REPORTER, A PROBE SLIPPED DURING PEDICLE PREP ON THE RIGHT T12 VERTEBRAE, RESULTING IN NEUROLOGICAL MOTOR LOSS. THE SURGEON ELECTED TO SKIP THE SCREW AT THAT LEVEL AND SIDE. THE RIGHT L1 SCREW WAS ALSO REMOVED AFTER DECREASED MOTOR ACTIVITY WAS OBSERVED.

  Patient problems: Numbness

  MAUDE report 23303284 ↗
• MalfunctionSep 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE 7D NAVIGATIONAL SYSTEM CRASHED TWICE WHILE ATTEMPTING A FLASH REGISTRATION ACQUISITION. THE SURGERY PROCEEDED WITH INTERMITTENT USE OF NAVIGATION, USING FLUORO MORE THAN ANTICIPATED. THIS RESULTED IN A SURGICAL DELAY OF MORE THAN 30 MINUTES. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965732 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER WHEN IMPLANTING THE L S2AI SECONDARY BOLT IT WAS PLACED MEDIAL AND INFERIOR TO THE SCIATIC NOTCH. CAUSING THE SCREW TO BE PLACED BY THE L ILIAC ARTERY AND VEIN. SCREWS WERE REPLACED USING FLUORO. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923919 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER PATIENT WOKE UP WITH PAIN POST-SURGICAL PROCEDURE. PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE SCREWS.

  Patient problems: Pain

  MAUDE report 22923907 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER, DURING FINAL SPIN IT WAS IDENTIFIED SCREW WAS PLACED MEDIAL AND NOT IN BONE. SCREWS WERE REMOVED AND REPLACED. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923905 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER, SURGEON WAS NAVIGATING AN L5-S1 FUSION WITH TWO ILIAC BOLTS. IT WAS DISCOVERED THAT BOTH BOLTS IN THE RIGHT SIDE WERE IN SOFT TISSUE. NAVIGATION WAS ABANDONED AND SURGICAL PROCEDURE PROCEEDED WITH FLUORO. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923904 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER DURING NAVIGATION, SURGEON EXPRESSED THAT HE FELT THE NAVIGATION WAS INACCURATE BUT CONTINUED TO SUPPLEMENT FREEHAND TECHNIQUE WITH INTERMITTENT USE OF NAVIGATION. PATIENT WAS REPORTED TO HAVE EXPERIENCED BLOOD LOSS DURING THE SURGICAL PROCEDURE AND REMAINED IN THE ICU.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vertebral Fracture

  MAUDE report 22923901 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED POST ROUTINE BIOPSY PATIENT BEGAN EXPERIENCING SYMPTOMS PROMPTING A FOLLOW UP MRI. AS PER REPORTER IT WAS IDENTIFIED PATIENT HAD EXPERIENCED A HEMORRHAGE CAUSING A CRANIOTOMY. NO ALLEGATION OF PRODUCT MALFUNCTION WAS REPORTED. PATIENT WAS REPORTED TO HAVE GRADUAL IMPROVEMENTS. IT WAS REPORTED POST ROUTINE BIOPSY PATIENT BEGAN EXPERIENCING SYMPTOMS PROMPTING A FOLLOW UP MRI. AS PER REPORTER IT WAS IDENTIFIED PATIENT HAD EXPERIENCED A HEMORRHAGE CAUSING A CRANIOTOMY. NO ALLEGATION OF PRODUCT MALFUNCTION WAS REPORTED. PATIENT WAS REPORTED TO HAVE GRADUAL IMPROVEMENTS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22923900 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TWO SCREWS NAVIGATED THROUGH THE DISC SPACE. 7D WAS ABANDONED AND SCREWS WERE PLACED WITH FLUORO. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923899 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS PER REPORTER A MEDIAL BREACH ON T2/3 WAS IDENTIFIED ON THE RIGHT SIDE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923898 ↗
• MalfunctionAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE THE REP TRIED TO RE-FLASH THE SYSTEM MULTIPLE TIMES UNSUCCESSFUL. THE SURGICAL CASE WAS CANCELLED AND WILL BE RESCHEDULED FOR A LATER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923897 ↗
• InjuryAug 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 29 JUL 2025, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING. PER THE REPORTER, THE SURGEON NAVIGATED RS1 TO RL2, CANNULATED VIA GEARSHIFT, AND PLACED SCREWS. ON LS1 A DISCREPANCY IN ACCURACY WAS NOTICED. FLUORO IMAGING WAS PERFORMED, AND IT WAS DISCOVERED THAT THE PREVIOUS 6 SCREWS WERE OFF EITHER LATERALLY, MEDIALLY, OR IN THE DISC SPACE. ALL SCREWS WERE REMOVED AND NAVIGATION ABORTED. THE PATIENT IS EXPERIENCING NUMBNESS IN ONE LEG AND THE OPPOSITE TOE/FOOT. THE SURGEON NOTED THAT THEY BOTH SEEM TO BE SUBSIDING.

  Patient problems: Numbness

  MAUDE report 22913418 ↗
• MalfunctionJun 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 09 MAY 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING. THE FIRST SCREW SKIVED MEDIALLY ACROSS SACRAL BRIDGE WHEN THE SACRAL BLOCK REGISTRATION WAS CLAMPED ONTO S1. ALL OTHER SCREWS IN BLOCK WERE ACCURATE. THE SURGEON OPTED TO SUSPEND 7D NAVIGATION AND SWITCH TO STEALTH/ O-ARM TO CORRECT RESULTING IN A DELAY OF GREATER THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 22160252 ↗
• MalfunctionMay 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING, THE L2-3 SEGMENT WAS NAVIGATED OFF OF L2 REGISTRATION WITHOUT ISSUE. NAVIGATION FOR L4 WAS SUBSEQUENTLY PERFORMED USING L3 REGISTRATION. INTRAOPERATIVE NAVIGATION IMAGES INDICATED THAT CANNULATIONS AND SCREWS WERE POSITIONED WITHIN THE PEDICLES. HOWEVER, AN O-ARM SPIN PERFORMED AT THE END OF THE CASE REVEALED A LATERAL BREACH OF THE RIGHT L3 SCREW. THE SURGICAL TEAM TRANSITIONED TO AN ALTERNATIVE NAVIGATION SYSTEM AND UTILIZED INTRAOPERATIVE O-ARM IMAGING TO REPOSITION THE AFFECTED SCREW. THE PROCEDURE PROCEEDED WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT INJURY; THE BREACH DID NOT CONTACT OR AFFECT ANY VESSELS OR NEURAL STRUCTURES. ALL SCREWS WERE SUCCESSFULLY REPOSITIONED, AND THE PATIENT IS REPORTED TO BE DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116635 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING WHILE PLACING THE LAST SCREW FOR A SEGMENTAL L4 REGISTRATION, THE SURGEON MADE A LATERAL HOLE AND WAS ASKED TO LOOK AT THE SCREEN TO CONFIRM THAT IT WAS ACCURATE. HE THEN MADE A NEW HOLE AND APPEARED TO PUT THE SCREW INTO THE INITIAL LATERAL HOLE. THE SURGEON PROCEEDED TO TAKE SCREW OUT WHICH LEAD TO THE PATIENT STARTING TO BLEED HITTING AN ARTERY. BASED ON DISCUSSION WITH THE SURGEON, THIS EVENT IS NOT THOUGHT TO BE THE FAULT OF NAVIGATION. THE SURGEON SUGGESTED THAT THE PATIENT MAY HAVE HAD ABNORMAL ANATOMY.

  Patient problems: Perforation

  MAUDE report 22101943 ↗
• MalfunctionMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING SPINAL NAVIGATION USING 7D SURGICAL FLASH IMAGING, THE SURGEON FELT THAT HE WAS MORE SUPERIOR THAN WHAT THE NAVIGATION WAS SHOWING. HE THEN USED FLUORO TO CONFIRM AND IT REVEALED THE 7D IMAGING WAS OFF BY APPROXIMATELY 4-5MM. THE SURGEON PROCEEDED WITH A HYBRID OF NAVIGATION AND FLUORO, WHICH EXPOSED THE PATIENT TO A HIGH DOSE OF RADIATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081822 ↗
• MalfunctionMay 8, 2025Use of Device Problem; Use of Device Problem

  DURING SPINAL NAVIGATION USING 7D SURGICAL FLASH IMAGING, THE SURGEON PERFORMED A UNILATERAL REGISTRATION AT L4. POINT 2 WAS REGISTERED HIGH, AND ALTHOUGH THE ACCURACY CHECK APPEARED ACCEPTABLE AT THE TIME, THE SYSTEM DID NOT CAPTURE THE ANATOMY CLEARLY DUE TO POOR EXPOSURE AND SHADOWING IN THE FLASH IMAGE. AS A RESULT, A PEDICLE SCREW WAS INADVERTENTLY PLACED INTO THE DISC SPACE. THE ERROR WAS IDENTIFIED INTRAOPERATIVELY, AND THE SCREW WAS REPOSITIONED USING FLUOROSCOPIC GUIDANCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND DID NOT REQUIRE FURTHER INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988828 ↗
• MalfunctionFeb 5, 2025Calibration Problem; Positioning Problem; Calibration Problem; Positioning Problem

  DURING NAVIGATION, SURGEON REGISTERED C2 FIRST AND GOT MINIMAL GREEN ON THE LEFT SIDE. BUT SURGEON DID ACCURACY CHECK AND DEEMED IT OK. PROCEEDED TO DRILLED LEFT C2 FIRST AND PUT A SCREW IN USING FLASHLOCK. SURGEON SAID THE FLASHLOCK WAS OFF AS THE SCREW LOOKED TO BE INCORRECTLY PLACED AND MOVED TO THE RIGHT-HAND SIDE. DRILL AND SCREW AGAIN USING FLASHLOCK LOOKED TO BE OK. PROCEEDED TO MOVE TO C1 AND RE-REGISTERED. SURGEON SAID DRILL (UNIVERSAL TRACKER) WAS INACCURATE SO WE RE-REGISTERED. DRILL AND FLASHLOCK THE SCREW RIGHT SIDE THEN LEFT. WE DID AN O-ARM SPIN AT THE END OF THE CASE. RIGHT C2 SCREW AND BOTH C1 SCREWS ALL OK. LEFT C2 SCREW HAS REACHED THE VERTEBRAL ARTERY. THE ARTERY WAS BREACHED. THE SURGEON DECIDED TO LEAVE THE SCREW IN THAT POSITION AS REMOVING IT MAY HAVE CAUSED FURTHER DAMAGE AND BLEEDING CONTROL ISSUES. PATIENT STATUS IS BEING MONITORED INITIALLY AS OF (B)(6)2024 - PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315716 ↗
• InjuryJul 24, 2024Use of Device Problem; Use of Device Problem

  THE PRIMARY SPINAL FUSION SURGERY TOOK PLACE ON (B)(6)2024. THE SURGEON REGISTERED TO L4 AND L5 AND ACCEPTED REGISTRATION VERIFICATION AND PROCEEDED TO NAVIGATE. FOUR SCREWS WERE PLACED WITH 7D NAVIGATION WITH NO CONCERNS THROUGHOUT NAVIGATION. FROM INTRA-OPERATIVE X-RAYS TAKEN DURING THE PROCEDURE AFTER FINAL ROD PLACEMENT, IT WAS NOTED THAT THE LEFT L5 SCREW HAD BREACHED THE SUPERIOR ENDPLATE AND ENTERED THE DISC SPACE. THE SURGEON THEN DECIDED TO COMPLETE THE SURGERY AND SCHEDULE A REVISION PROCEDURE TWO DAYS LATER. 7D SURGICAL WAS NOTIFIED THAT THE REVISION SURGERY WAS COMPLETE ON (B)(6)2024. ON (B)(6)2024, 7D SURGICAL WAS NOTIFIED THAT THE PATIENT IS STABLE AND IN GOOD CONDITION, AS REPORTED BY THIS PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823171 ↗
• InjuryNov 27, 2023Use of Device Problem; Use of Device Problem

  THE PRIMARY SPINAL FUSION SURGERY TOOK PLACE ON SEPTEMBER 25, 2023. THE SURGEON REGISTERED TO L5 AND S1 AND CONFIRMED REGISTRATION ACCURACY BEFORE PROCEEDING TO NAVIGATE. THE NAVIGATED PEDICLE PROBE WAS USED TO CANNULATE EACH PEDICLE AND THE SCREWS WERE PLACED IN THE CANNULATION. FOUR PEDICLES WERE CANNULATED WITH 7D NAVIGATION WITH NO CONCERNS AT THE TIME OF SURGERY. THE SURGEON PLACED SCREWS ON ONE SIDE AND HAD A SECONDARY SURGEON PLACE SCREWS ON THE CONTRALATERAL SIDE. INTRAOPERATIVE X-RAYS WERE TAKEN TO CONFIRM SCREW POSITIONING DURING THE PROCEDURE. UPON A FOLLOW-UP POSTOPERATIVE CT, IT WAS NOTED THAT THE L5 RIGHT SCREW HAD BREACHED THE PEDICLE MEDIALLY. THE PATIENT REQUIRED A REVISION SURGERY TO REPOSITION THE SCREW. THE REVISION SURGERY WAS PERFORMED WITHOUT NAVIGATION. 7D SURGICAL WAS NOTIFIED OF THE REVISION SURGERY ON (B)(6) 2023. ON (B)(6) 2023, 7D SURGICAL WAS NOTIFIED THAT THE PATIENT WAS EXHIBITING A SENSORY DEFICIT.

  Patient problems: Nerve Damage

  MAUDE report 18210982 ↗
• InjuryNov 27, 2023Use of Device Problem; Use of Device Problem

  THE PRIMARY SPINAL FUSION SURGERY TOOK PLACE ON OCT 25, 2023. THE SURGEON REGISTERED TO L4 AND CONFIRMED REGISTRATION ACCURACY BEFORE PROCEEDING TO NAVIGATE. THE NAVIGATED PEDICLE PROBE WAS USED TO CANNULATE EACH PEDICLE AND THE SCREWS WERE PLACED IN THE CANNULATION. FOUR PEDICLES WERE CANNULATED WITH 7D NAVIGATION WITH NO CONCERNS AT THE TIME OF SURGERY. THE SURGEON PLACED SCREWS ON ONE SIDE AND HAD A SECONDARY SURGEON PLACE SCREWS ON THE CONTRALATERAL SIDE. INTRAOPERATIVE X-RAYS WERE TAKEN TO CONFIRM SCREW POSITIONING DURING THE PROCEDURE. UPON A FOLLOW-UP POSTOPERATIVE CT, IT WAS NOTED THAT THE L4 RIGHT SCREW HAD BREACHED THE PEDICLE MEDIALLY. THE PATIENT REQUIRED A REVISION SURGERY TO REPOSITION THE SCREW. THE REVISION SURGERY WAS PERFORMED WITHOUT NAVIGATION. 7D SURGICAL WAS NOTIFIED OF REVISION SURGERY ON (B)(6) 2023. ON (B)(6) 2023, 7D SURGICAL WAS NOTIFIED THAT THE PATIENT WAS EXHIBITING A NEUROLOGICAL DEFICIT.

  Patient problems: Nerve Damage

  MAUDE report 18210634 ↗