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NVM5 NVM5IIRecalls & reported problems

Nuvasive, Inc. · NVM5 with EMG, MEP and Guidance · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517089151), received between May 16, 2016 and May 16, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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

Device problems

  • False Negative Result1

Patient problems

  • Nerve Damage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 16, 2016False Negative Result; False Negative Result

    SURGERY TO PERFORM A FUSION PROCEDURE AT L5-S1 SPINE LEVELS VIA XLIF PROCEDURE FOLLOWED BY PLACEMENT OF POSTERIOR FIXATION OCCURRED ON (B)(6) 2012. SHORTLY AFTER SURGERY, THE PATIENT WAS REPORTED TO HAVE HAD SYMPTOMS NECESSITATING SURGICAL INTERVENTION. IT WAS REPORTED THE NEUROMONITORING DEVICE FAILED TO DETECT PROXIMITY OF THE PEDICLE SCREWS TO NERVES, RESULTING IN NERVE INJURY. REVISION SURGERY OCCURRED ON (B)(6) /2012 IN WHICH REPOSITIONING OF THE SCREWS WAS PERFORMED. THE PATIENT REPORTED THAT A PERMANENT "FOOT DROP-LIKE CONDITION AND CHRONIC PAIN" RESULTED FROM THE EVENT.

    Patient problems: Nerve Damage

    MAUDE report 5658465 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.