MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16014540
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.No x-rays or mri provided to confirm the alleged event.Multiple attempts have been made to try and retrieve further event information.Labeling review: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: loss of sensory and/or motor function." no product malfunction reported.
Event or Problem Description
On (b)(6) 2018, patient underwent spinal fusion procedure at t9-s2 levels and spinal decompression at t5/6 using multiple products.Post-operative patient was experiencing no leg movement.A diagnostic imaging, ct and mri, were performed and revealed a signal change at levels t6/7.A revision procedure to extend the construct is planned.
Event or Problem Description
New information received indicates patients underwent a revision procedure on (b)(6) 2018.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego 92121
• MDR Report Key: 7970247
• Report Number: 2031966-2018-00155
• Device Sequence Number: 1572570
• Product Code: NKB
• UDI-Device Identifier: 00887517552853
• UDI-Public: 887517552853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16014540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR