NVM5 2021000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517168603), received between Aug 21, 2022 and Aug 23, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 16, 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.

• InjuryAug 23, 2023Communication or Transmission Problem; Insufficient Device Problem Information; Communication or Transmission Problem; Insufficient Device Problem Information

  UPDATED INFORMATION IN H10.

  Patient problems: Nerve Damage

  MAUDE report 17603037 ↗
• MalfunctionAug 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317126 ↗
• MalfunctionAug 21, 2022Electromagnetic Interference; Electromagnetic Interference

  ON (B)(6) 2022 DURING AN EXTREME LATERAL INTERBODY FUSION AN NVM5 SYSTEM DISPLAYED A NOTIFICATION THAT INDICATED THERE WAS "ELECTOCAUTERY INTERFERENCE" AND STIMULATION COULD NOT BE PERFORMED. TROUBLESHOOTING WAS PERFORMED BY SWITCHING OFF THE BED AND ELECTOCAUTERY UNIT, ENSURING THE X-RAY WAS AT A DISTANCE, AND REPLACING THE GROUND ELECTRODES; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE SURGEON ALTERED THE SURGICAL PLAN AND PROCEEDED WITH A POSTERIOR TRANSFORAMINAL LUMBAR INTERBODY FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263566 ↗

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