NVM5 2029950Recalls & reported problems
Nuvasive, Inc. · NVM5 XLIF Dilator Kit, Pkg Ster · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517170606), received between Jun 1, 2018 and Feb 2, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Imprecise or Erratic Results1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 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 NEUROMONITORING VIA ELECTROMYOGRAPHY IN AN EXTREME LATERAL INTERBODY FUSION PROCEDURE, INCONSISTENT VALUES RELATED TO NERVE PROXIMITY/DIRECTIONALITY WERE OBTAINED WHILE USING THE DILATORS. SPECIFICALLY, THE 6MM DILATOR GAVE VALUES OF =20MA WHILE THE 9MM AND 12MM DILATORS GAVE VALUES OF <5MA IN ALL DIRECTIONS. ATTEMPTS TO RESOLVE BY REPOSITIONING THE DILATORS WERE UNSUCCESSFUL. REPORTEDLY, SMALL PARTICLES WERE NOTED TO BE ATTACHED TO THE K-WIRE AFTER IT WAS REMOVED FROM THE 6MM DILATOR. A NEW SET OF DILATORS WAS AVAILABLE AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634416 ↗MalfunctionOct 25, 2022Imprecise or Erratic Results; Imprecise or Erratic Results
THIS IS A DUPLICATE OF REPORT 2031966 - 2022 - 00223 AND FOLLOW UP REPORT 2031966 - 2022 - 00223 DETAILS ON SEC H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670610 ↗MalfunctionJun 1, 2018Leak/Splash; Device Contamination with Chemical or Other Material
LATERAL LUMBAR INTERBODY FUSION (XLIF) WITH DR. NUVASIVE NVM5 XLIF DISPOSABLE KIT, REF: 2029950, LOT: 1802231, EXP: 2023-01-22, HAD BLACK INK LIKE SUBSTANCE COME OFF OF DILATOR (LOOKS LIKE FROM THE INSIDE OF THE BLUE (LARGEST) DILATOR). CONTAMINATED ITEMS REMOVED FROM SURGICAL FIELD. DILATORS WITH PACKAGING SENT TO RISK MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7560685 ↗
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- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.