MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number NVM5II

Device Problem False Negative Result (1225)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Evaluation of the device has not been possible.No information related to the performance of the device during the surgery has been available for evaluation, although the device's service history does not indicate problems related to failure to detect nerve proximity.No report of malfunction prior to or after the index surgery was reported to nuvasive.No information about the patient's prior nerve conduction capability are known.It is not known if post-placement testing of pedicle screws was performed.Labeling review: warning: chronically compressed nerves, or severely compressed nerves in an acute setting, are known to be less sensitive to depolarization currents (i.E., have significantly higher depolarization current values).They are also less likely to demonstrate significant changes in their threshold depolarization current values immediately following nerve decompression.Under such circumstances, exercise caution in interpreting displayed data.Device unavailable.

Event Description

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.

• Brand Name: NUVASIVE NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: paul holbrook ; 7475 lusk boulevard; san diego, CA 92121 ; 8583205285
• MDR Report Key: 5658465
• MDR Text Key: 45276517
• Report Number: 2031966-2016-00039
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517089151
• UDI-Public: 00887517089151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NVM5II
• Device Catalogue Number: NVM5II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability