PULSE 1881500Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00887517990792), received between Oct 28, 2021 and Feb 2, 2024 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A DURING A PROCEDURE USING PULSE NAVIGATION A NAVIGATIONAL INACCURACY WAS SEEN WHEN INITIATING A TAP FOR THE RIGHT L4 PEDICLE SCREW. AFTER INITIATION OF THE TAP THE SURGEON REMARKED THAT THE ACCURACY APPEARED TO BE OFF. 2D X-RAY IMAGES WERE TAKEN AND CONFIRMED THE INITIAL TAP TRAJECTORY WAS MORE LATERAL THAN PLANNED. THE INITIAL TAP TRAJECTORY WAS NOT USED AND A SCREW WAS PLACED UNDER 2D X-RAY IN IN THE CORRECT POSITION. NAVIGATION WAS USED IN CONJUNCTION WITH 2D X-RAY FOR THE REMAINDER OF THE CASE AND SCREW PLACEMENT WAS FOUND TO CORRESPOND CORRECTLY ACROSS BOTH THE NAVIGATION AND X-RAY IMAGES, INDICATING ACCURATE NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636235 ↗
• MalfunctionNov 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION WITH POSTERIOR FIXATION USING PULSE SYSTEM NAVIGATION. DURING PEDICLE SCREW PLACEMENT FOR THE POSTERIOR PORTION OF THE CASE THE SURGEON PLACED A SCREW THAT WAS ACCURATE, THEN A SECOND SCREW WAS PLACED, WHICH THE SURGEON FELT WAS INACCURATE. THE SURGEON STIMULATED THE PLACED SCREW, WHICH DISPLAYED RED, INDICATING THE SCREW WAS CLOSE TO A NERVE, CONFIRMING IT WAS NOT PLACED IN THE INTENDED LOCATION. THE MALPLACED SCREW WAS REMOVED. THE TRACKING REFERENCE ARRAY WAS RE-SECURED. SYSTEM ACCURACY WAS RE-ESTABLISHED. THE CASE WAS CONTINUED WITH THE REMAINING SCREWS PLACED ACCURATELY AND NO ADDITIONAL ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234705 ↗
• InjuryOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN L3 TO L5 EXTREME LATERAL INTERBODY FUSION WITH L5 TO S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION AND POSTERIOR SPINAL FUSION CASE USING THE PULSE SYSTEM FOR NEUROMONITORING. DURING PATIENT REPOSITIONING TO PRONE FOR THE POSTERIOR FUSION PORTION OF THE PROCEDURE, THE CONNECTION TO NEUROMONITORING WAS LOST. TROUBLESHOOTING WAS ABLE TO RE-ESTABLISH THE CONNECTION; HOWEVER, THE SURGEON DID NOT WANT TO CONTINUE MONITORING; THUS, NO NEUROMONITORING WAS USED DURING THE POSTERIOR PORTION OF THE CASE. POST-OPERATIVE EVALUATION IDENTIFIED THAT THE PATIENT HAD SUSTAINED A LEFT LEG DEFICIT. PER THE SURGEON, IT IS UNKNOWN WHETHER THE SYSTEM DID NOT ACCURATELY REPRESENT NERVE PROXIMITY OR THE PATIENT DID NOT RESPOND TO STIMULATION AS TYPICALLY EXPECTED.

  Patient problems: Nervous System Injury

  MAUDE report 18016898 ↗
• MalfunctionOct 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SCREW PLACEMENT WHEN THE PATIENT WAS IN A LATERAL POSITION, THE PULSE SYSTEM WAS DISPLAYING A NAVIGATIONAL INACCURACY. DETAILS REGARDING THE TYPE OF INACCURACY AND THE PATIENT IMPACT WERE REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935277 ↗
• InjuryAug 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT RECEIVED A LAMINECTOMY AT THE INCORRECT LEVEL DURING A PROCEDURE UTILIZING PULSE. THE PROCEDURE WAS INTENDED TO BE A T10 LAMINECTOMY ALONG WITH L4-S1 POSTERIOR INTERBODY FUSION. PULSE, SPECIFICALLY THE LESSRAY APPLICATION, WAS UTILIZED TO PERFORM IMAGE STITCHING OF THE PATIENT'S VERTEBRAL ANATOMY TO IDENTIFY THE LEVEL FOR THE LAMINECTOMY; THE STITCHING WAS COMPLETED WITH ASSISTANCE OF THE RADIOGRAPHER. DURING THE PROCEDURE, THE LESSRAY STITCHED IMAGE WAS VISIBLE ON BOTTOM MONITOR OF PULSE AND THE LAMINECTOMY LEVEL LABELS WERE APPLIED UNDER SURGEON SUPERVISION. IT WAS NOTED BY THE SURGEON THAT THE PATIENT'S ILIAC CREST POSITION MADE IDENTIFICATION OF VERTEBRAL ANATOMY ON THE IMAGING DIFFICULT. THE SURGEON PLACED A SYRINGE MARKER AT THE LABELED LEVEL FOR THE LAMINECTOMY. THE LAMINECTOMY WAS THEN CONDUCTED AND COMPLETED UNDER EXTERNAL NEUROMONITORING; NO NEGATIVE FEEDBACK ENCOUNTERED DURING THE CASE. SURGEON THEN PROCEEDED TO PERFORM THE L4-S1 POSTERIOR INTERBODY FUSION PORTION OF THE PROCEDURE WITH NO ISSUES ENCOUNTERED. HOWEVER, THE NEXT DAY IT WAS DISCOVERED THAT THE LAMINECTOMY HAD BEEN PERFORMED AT ONE LEVEL INFERIOR TO THE INTENDED LEVEL. SUBSEQUEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490968 ↗
• MalfunctionMay 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A NON-NUVASIVE DEVICE, INDICATED FOR USE WITH THE SYSTEM, WAS USED TO DRILL A PILOT HOLE IN THE PEDICLE ON AN UNKNOWN SPINAL LEVEL USING NAVIGATION. A PEDICLE SCREW WAS THEN INSERTED INTO THE HOLE BUT A SUBSEQUENT CONFIRMATION SCAN FOUND THE SCREW TO BE A FEW MILLIMETERS DEEPER THAN INTENDED AND THAT THE ACCURACY OF THE NAVIGATED DRILL APPEARED TO BE A FEW MILLIMETERS OFF IN DEPTH. THE SURGEON REPORTED THE SCREW POSITION WAS CONSIDERED ACCEPTABLE AND NO SCREW REPLACEMENT WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004428 ↗
• MalfunctionMar 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023 DURING AN L4/5 XLIF CASE A SURGEON REPORTED RECEIVING STIMULATION CURRENT READINGS THAT WERE LOWER THAN EXPECTED WHILE USING THE PULSE SYSTEM INTEROPERATIVE NEUROMONITORING. LOW STIMULATION CURRENT READINGS INDICATED THE SYSTEM WAS WARNING THAT NERVE PROXIMITY WAS CLOSER THAN EXPECTED. LOW STIMULATION CURRENT READINGS WERE SEEN ON ALL THREE (3) DILATOR SIZES USED DURING THE CASE. A NUVASIVE REPRESENTATIVE WAS NOTIFIED ABOUT THE ISSUE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600780 ↗
• MalfunctionMar 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, DURING AN L4/5 XLIF CASE A SURGEON REPORTED RECEIVING STIMULATION CURRENT READINGS THAT WERE LOWER THAN EXPECTED WHILE USING THE PULSE SYSTEM INTEROPERATIVE NEUROMONITORING. LOW STIMULATION CURRENT READINGS INDICATED THE SYSTEM WAS WARNING THAT NERVE PROXIMITY WAS CLOSER THAN EXPECTED. LOW STIMULATION CURRENT READINGS WERE SEEN ON ALL THREE (3) DILATOR SIZES USED DURING THE CASE. A NUVASIVE REPRESENTATIVE WAS NOTIFIED ABOUT THE ISSUE ON 28 FEB 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600772 ↗
• MalfunctionMar 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A POSTERIOR FIXATION PROCEDURE WAS PERFORMED UTILIZING THE PULSE SYSTEM NAVIGATION FOR PEDICLE SCREW PLACEMENT. AFTER A PEDICLE SCREW WAS INSERTED AT AN UNKNOWN SPINE LEVEL, A CONFIRMATION SCAN WAS CONDUCTED AND FOUND THE SCREW WAS PLACED MORE MEDIAL THAN INTENDED. THE SCREW WAS REMOVED AND THE SAME SCREW WAS REPOSITIONED IN THE CORRECT ORIENTATION USING A FREEHAND TECHNIQUE. PULSE SYSTEM NAVIGATION WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. FOLLOWING THE PROCEDURE, A SYSTEM ACCURACY CHECK WAS PERFORMED AND THE SYSTEM WAS FOUND TO BE CALIBRATED APPROPRIATELY WITH NO INACCURACY. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552917 ↗
• MalfunctionDec 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CASE WAS PERFORMED ON (B)(6) 2022 OPERATING ON L3 TO L5 USING THE PULSE SYSTEM NAVIGATION. WHILE NAVIGATING WITH A NON-NUVASIVE, OFF-LABEL, DEVICE NOT INDICATED FOR USE WITH THE PULSE SYSTEM, THE LEFT L4 CANNULATION WAS NOT ACCURATE RESULTING IN A PEDICLE SCREW THAT WAS NOT PLACED IN THE INTENDED LOCATION. THE LEFT L4 SCREW WAS REMOVED AND REPLACED IN THE CORRECT LOCATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045611 ↗
• MalfunctionDec 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CASE WAS PERFORMED ON (B)(6) 2022 OPERATING ON L1 TO L2 USING THE PULSE SYSTEM NAVIGATION. WHILE NAVIGATING WITH A NON-NUVASIVE DEVICE INDICATED FOR USE WITH THE PULSE SYSTEM, THE RIGHT L1 CANNULATION WAS NOT ACCURATE RESULTING IN A PEDICLE SCREW THAT WAS NOT PLACED IN THE INTENDED LOCATION. THE RIGHT L1 SCREW WAS REMOVED AND REPLACED IN THE CORRECT LOCATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992613 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE WAS PERFORMED ON PATIENT LEVELS T10 TO PELVIS IN WHICH THE SURGEON USED PULSE NAVIGATION FOR PEDICLE TARGETING VIA THE USE OF A POINTER. AFTER IDENTIFYING THE SCREW INSERTION LOCATION AND TRAJECTORY VIA SYSTEM NAVIGATION THE SURGEON THEN CANNULATED THE PEDICLE WITH A FREEHAND TECHNIQUE. A BALL TIP FEELER WAS THEN USED TO FEEL FOR BONE WITHIN THE CANNULATED PEDICLE AND THE SCREWS WERE PLACED. FOLLOWING SCREW PLACEMENT IT WAS NOTED THAT THE RIGHT T10 AND T11 SCREWS WERE IN AN UNFAVORABLE POSITION. ON A POST OPERATIVE EXAMINATION THE PATIENT REPORTED RIGHT LEG FEELING LOSS AND FOOT DROP. AS OF (B)(6) 2022, THE PATIENT HAS REGAINED SOME FEELING BUT FOOT DROP STILL PRESENT.

  Patient problems: Nerve Damage

  MAUDE report 15905866 ↗
• MalfunctionOct 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING AN EXTREME LUMBAR INTERBODY FUSION ON THE L4-5 WHILE USING ELECTROMYOGRAPHY (EMG) ON A SURGICAL DILATOR, THE SYSTEM NOTIFIED THE SURGEON THAT THE DILATOR WAS IN CLOSE PROXIMITY TO A NERVE IN EVERY DIRECTION TESTED, WHICH THE SURGEON BELIEVED TO BE INCORRECT. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655267 ↗
• MalfunctionOct 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING A CASE, FOLLOWING INSTRUMENT REGISTRATION AND AN ACCURACY CHECK USING ANATOMICAL LANDMARKS USING A POINTER, K-WIRES WERE PLACED IN THE PATIENT. A 2D RADIOGRAPH RADIOGRAPH WAS THEN TAKEN, AT WHICH POINT THE SURGEON NOTED THAT THE K-WIRES THAT WERE PLACED USING SURGICAL NAVIGATION LOOKED TOO LOW RELATIVE TO THE INTENDED LOCATION. AN ADDITIONAL ARRAY REGISTRATION WAS CONDUCTED TO TROUBLESHOOT THE INACCURACY; HOWEVER, THE SYSTEM'S SUGGESTED TRAJECTORIES WERE STILL INACCURATE. AN ALTERNATE IMAGING SYSTEM WAS BROUGHT IN TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579963 ↗
• MalfunctionJul 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING THE CONFIRMATION SCAN OF A NAVIGATED L4 TO L5 ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE THE SURGEON NOTED THAT THE LEFT AND RIGHT SCREWS PLACED ON L4 WERE MALPLACED. THE SURGEON NOTED THAT THE NAVIGATION WAS PRESENTING 2MM PROUD AND 3MM CAUDAL TO THE ACTUAL PLACEMENT. THE SCREWS WERE REMOVED, THE PATIENT WAS RE-SCANNED, AND THE SCREWS WERE REPLACED CORRECTLY UNDER NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033074 ↗
• MalfunctionJul 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING A CONFIRMATION RADIOGRAPH SCAN IN A NAVIGATED MIS SURGICAL CASE IT WAS DETERMINED THAT THE SCREWS PLACED ON THE RIGHT SIDE OF THE L2, L4, AND L5 VERTEBRAE WERE MALPLACED WHILE SCREWS ON THE LEFT SIDE WERE DETERMINED TO BE ACCURATELY PLACED. THE MALPLACED SCREWS WERE OBSERVED AND CORRECTED DURING THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033059 ↗
• MalfunctionMay 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PATIENT UNDERWENT A L2-L5 EXTREME LATERAL INTERBODY FUSION WITH POSTERIOR FIXATION CASE FOR WHICH PULSE III SYSTEM NAVIGATION WAS USED. FOLLOWING THE PLACEMENT OF TWO POSTERIOR SCREWS THE SURGEON NOTED THE SYSTEM WAS DISPLAYING AN INACCURATE SCREW TRAJECTORY AND DETERMINED THAT THE SCREWS HAD BEEN MALPLACED. THE TWO SCREWS WERE REPLACED CORRECTLY AND THE CASE WAS FINISHED USING AN ALTERNATE SURGICAL TECHNIQUE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519825 ↗
• InjuryNov 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device

  ON (B)(6) 2021 AN OPEN POSTERIOR SPINAL FUSION WAS PERFORMED ON T10 TO S1 WITH THE ASSISTANCE OF NAVIGATION USING THE NUVASIVE PULSE III SYSTEM. DURING THE PROCEDURE, FOLLOWING PLACEMENT OF EIGHT PEDICLE SCREWS, THE SURGEON CONFIRMED THE SCREW PLACEMENT USING FLUOROSCOPY AND OBSERVED SEVEN MISPLACED SCREWS THAT HAD LATERALLY BREACHED. THE SURGEON REMOVED AND REPLACED THE SEVEN SCREWS INTO THEIR INTENDED POSITIONS USING FLUOROSCOPY AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vertebral Fracture

  MAUDE report 12897561 ↗
• MalfunctionOct 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Delivery; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Delivery

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LUMBER FIXATION PROCEDURE WITH THE ASSISTANCE OF NAVIGATION. DURING THE PROCEDURE, FOLLOWING PLACEMENT OF THE PEDICLE SCREWS, THE SURGEON HAD CONCERNS WITH THE NAVIGATION ACCURACY. THE SCREW PLACEMENT WAS REVIEWED UNDER FLUOROSCOPY AND TWO (2) MISPLACED SCREWS WERE OBSERVED. THE SURGEON REPOSITIONED THE SCREWS USING FLUOROSCOPY TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716581 ↗
• MalfunctionOct 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716569 ↗
• MalfunctionOct 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FIVE (5) LEVEL POSTERIOR LUMBER FIXATION PROCEDURE UTILIZING THE ASSISTANCE OF NAVIGATION TO PLACE A K-WIRE IN EACH PEDICLE LOCATION WHERE THE FINAL SCREW WOULD BE IMPLANTED. FOLLOWING PLACEMENT OF THE K-WIRES, THE SURGEON UTILIZED FLUOROSCOPY TO REVIEW PLACEMENT AND IDENTIFIED THAT MOST K-WIRES WERE MISPOSITIONED CAUDAL FROM THE INTENDED PLACEMENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716566 ↗