MAUDE Adverse Event Report: NUVASIVE, INCORPORATED; UNKNOWN DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

No product information provided or returned.No product malfunction was alleged.No root cause could be determined due to a lack of information provided.No additional investigation can be completed at this time.

Event Description

On (b)(6) 2020 a patient underwent an extreme lateral interbody fusion at t10/11.Neuromonitoring was supplied by another manufacturer.Immediately post-op the patient reportedly had zero lower limb movement.Later that evening the patient's foot control returned.The patient reportedly continued to stay in the ward.No further complications or revision surgery reported.

• Type of Device: UNKNOWN DEVICE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10993158
• MDR Text Key: 221241270
• Report Number: 2031966-2020-00217
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization