REMI Robotic Navigation System PN-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850026574340), received between Apr 19, 2022 and Feb 10, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Positioning Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023Positioning Failure; Positioning Failure

  ON 11-JAN-2023 ACCELUS WAS MADE AWARE OF A COMPLAINT ON THE REMI ROBOTIC NAVIGATION SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE PEDICLE SCREWS THAT WERE PLACED INFERIOR TO THE PEDICLE DURING THE INITIAL SURGERY. THE INITIAL SURGERY WAS A LEFT L4/L5 ENDO TLIF, WITH LINESIDER MIS AND REMI WITH O-ARM REGISTRATION. IT WAS REPORTED THAT DURING THE INITIAL SURGERY THE SYSTEM WAS USED WITHOUT CONNECTION OF THE CAMERA TO A PSIS PIN AS INDICATED IN THE REMI INSTRUCTIONS FOR USE. IT WAS REPORTED THAT AFTER THE INITIAL SURGERY THE PATIENT EXPERIENCED LEFT SIDE PAIN UPON WEIGHT BEARING AND A CT SCAN PERFORMED TO FIND THE LEFT L4 AND LEFT L5 PEDICLE SCREWS WERE INFERIOR TO THE PEDICLES BY A SIMILAR DISTANCE (ROUGHLY 5 MM). THE PATIENT WAS THEN TAKEN BACK TO THE OR 3 DAYS LATER AND REVISION OF BOTH THE LEFT L4 AND L5 PEDICLE SCREWS WAS PERFORMED USING STEALTH NAVIGATION AND GUIDEWIRES WITH LINESIDER MIS SCREWS. THE REVISION SURGERY WAS COMPLETED WITHOUT ISSUE AND NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT.

  Patient problems: Pain

  MAUDE report 16356078 ↗
• InjuryMay 20, 2022Positioning Failure; Positioning Failure

  ON 21-APR-2022 ACCELUS WAS MADE AWARE OF A COMPLAINT ON THE REMI ROBOTIC NAVIGATION SYSTEM THAT OCCURRED DURING AN INITIAL 3-LEVEL PEDICLE SCREW FIXATION PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT ON INTRA-OPERATIVE IMAGING THE SURGEON CONFIRMED THAT THE LEFT L4 SCREW WAS MISPLACED. THE SCREW WAS REMOVED AND REPLACED WITHOUT USING THE REMI SYSTEM. POSTOPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL LEG PAIN. UPON IMAGING REVIEW, IT WAS NOTED THAT THE LEFT L4 SCREW WAS MEDIALIZED. IMAGING ALSO SHOWED INFERIOR (A LOWER DOWN POSITION) PEDICLE SCREW PLACEMENT OF ALL SCREWS IN THE CONSTRUCT. THE SURGEON REPORTED THAT AT THE TIME OF THE SURGERY HE FELT THE PLACING OF THE LEFT L4 SCREW FELT "OFF" EVEN AFTER HE REPLACED IT AND ADDITIONALLY NOTED FIGHTING SOFT TISSUE ON PLACEMENT OF ALL 6 SCREWS IN THE CONSTRUCT. DURING THE INITIAL SURGERY THE SURGEON USED A DRILL GUIDE PROVIDED BY A THIRD PARTY. THE SURGEON REPORTED THAT HE NOW BELIEVED THAT THE LACK OF TEETH ON THE DRILL GUIDE DID NOT ALLOW IT TO SEAT WELL ON THE BONE CAUSING SKIVE AND THE RESULTING SCREW MISPLACEMENT. IT WAS ALSO REPORTED THAT THE SYSTEM WAS USED WITHOUT CONNECTION OF THE CAMERA TO A PSIS PIN AS INDICATED IN

  Patient problems: Pain

  MAUDE report 14464166 ↗
• InjuryApr 19, 2022Positioning Failure; Positioning Failure

  ON 21MAR2022 ACCELUS WAS INFORMED OF A COMPLAINT ON THE REMI SURGICAL GUIDANCE SYSTEM. IT WAS REPORTED THAT AN INITIAL CORTICAL PEDICAL SCREW FIXATION PROCEDURE WAS PERFORMED ON (B)(6) 2022. SUBSEQUENTLY, THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF LEFT LEG PAIN. UPON 3D IMAGING REVIEW, IT WAS NOTED THAT THERE WERE MISPLACED SCREWS DURING THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE THE SCREWS. NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT OF THE REVISION SURGERY. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Pain

  MAUDE report 14146799 ↗