NVM5 2021001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887517168610), received between Mar 4, 2022 and Aug 29, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K143641); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A NEUROMONITORING SYSTEM USED DURING A SCOLIOSIS CORRECTION CASE FROM T2 TO T11 DID NOT DISPLAY NEUROLOGICAL ACTIVITY INDICATING ANY ISSUE COMMENSURATE WITH THE POST-OPERATIVE COMPLETE MOTOR DEFICIT SUSTAINED BY THE PATIENT. IT WAS ALSO REPORTED THAT DURING THE CASE EMG INTERFERENCE WAS SEEN AS WELL AS UNILATERAL DELAYED RESPONSES ON A LOWER LIMB WHEN CONDUCTING MOTOR EVOKE POTENTIAL (MEP) STIMULATION. ADDITIONALLY, FOLLOWING THE CASE, MRI IMAGING REVEALED THAT A PEDICLE SCREW HAD BEEN PLACED IN THE SPINAL CANAL, FOR WHICH A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2023 TO REPLACE THE MALPLACED SCREW. SINCE THE REVISION IT WAS REPORTED THAT THE PATIENT HAD STARTED SHOWING SIGNS OF MOTOR RECOVERY.

  Patient problems: Paralysis

  MAUDE report 17647135 ↗
• InjurySep 16, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE WITH NEUROMONITORING. DURING THE PROCEDURE, IT WAS NOTED THAT THE SCREEN OF THE NEUROMONITORING UNIT WENT BLACK WHILE THE UNIT CONTINUED TO MAKE NOISE. AFTER SEVERAL ATTEMPTS, THE SCREEN TURNED ON; HOWEVER, DUE TO THE ISSUES ENCOUNTERED, THE SURGEON OPTED TO DISCONTINUE THE LATERAL APPROACH AND CONVERT THE PROCEDURE TO A POSTERIOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442498 ↗
• MalfunctionAug 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING ROUTINE SERVICING OF THE NVM5 UNIT, IT WAS FOUND THE UNIT FAILED SIMULATED STIMULATION TESTING; SPECIFICALLY, THE UNIT WAS NOT PROVIDING APPROPRIATE INDICATIONS OF STIMULATION VALUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312832 ↗
• MalfunctionApr 18, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  DURING ROUTINE SERVICING OF THE NVM5 UNIT, IT WAS FOUND THE UNIT FAILED SIMULATED STIMULATION TESTING; SPECIFICALLY, AN UNRESOLVABLE WINDOWS ERROR MESSAGE OCCURRED DURING DYNAMIC EMG STIMULATION, WHICH STOPPED STIMULATION FUNCTIONALITY. THE UNIT REQUIRED REIMAGING TO RESOLVE THE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137811 ↗
• MalfunctionApr 1, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  INITIALLY, IT WAS REPORTED THE UNIT WOULD NOT BOOT UP ENTIRELY AND WOULD FREEZE WITH A BLACK SCREEN. DURING SERVICE EVALUATION, IT WAS FOUND THE UNIT FAILED TO STIMULATE DURING SIMULATED STIMULATION TESTING. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13984513 ↗
• MalfunctionMar 4, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  WHILE ATTEMPTING TO START STIMULATION USING AN NVM5 DEVICE FOR NEUROMONITORING DURING AN EXTREME LATERAL INTERBODY FUSION (XLIF) PROCEDURE, THE NVM5 EXPERIENCED AN ERROR WHICH STOPPED STIMULATION FUNCTIONALITY. SEVERAL TROUBLESHOOTING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. AS A RESULT, NEUROMONITORING COULD NOT BE PERFORMED AND THE SURGEON HAD TO CHANGE THE SURGICAL PLAN, CLOSING THE XLIF SURGICAL SITE AND PERFORMING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE INSTEAD. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13674298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143641. One submission often covers many models, so check the product and lot details in each record.

• Z-2684-2020 · Jun 10, 2020 · Terminated
  Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal s