InjuryBXM
NUVASIVE NVM5 SYSTEM
Received Mar 28, 2012 · Event occurred Jan 26, 2011
Report 2031966-2012-00009 · MDR key 2518034
Device
Generic name
Electromyography (emg) Monitor / Stimulator
Manufacturer
Nuvasive, Inc.Model number
NVM5Catalog number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Nerve Damage
- Spinal Column Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT A SURGERY FOR AN L4-L5 DISC HERNIATION VIA TLIF APPROACH TO PERFORM DISCECTOMY AND FUSION THAT THE SURGEON CUT A NERVE ROOT THAT RESULTED IN PERMANENT NERVE DAMAGE. NO OTHER PATIENT INFO IS KNOWN.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS BEEN UNAVAILABLE FOR EVALUATION. NO ROOT CAUSE(S) OR CONTRIBUTING FACTORS RELATED TO THE INJURY HAVE BEEN ESTABLISHED.