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

Model Number	13115540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs or ct images provided.Review of the reported event suggests the paralysis is the result of an undiagnosed bone fragment or an unidentified vertebral fracture during the pedicle subtraction osteotomy.No product malfunction alleged.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." ".Potential risks identified with the use of this system, which may require additional surgery include, bending, fracture or loosening of implant component, loss of fixation, nonunion or delayed union, fracture of the vertebra, neurological, decrease in bone density due to stress shielding, paralysis." device is left insitu.
Event or Problem Description
On (b)(6) 2019, patient underwent a pedicle subtraction osteotomy at l3 with posterior fixation at l2 to l4 levels.Post operatively the patient experienced paralysis.As per reporter a revision procedure was performed to remove vertebral disc at l2 to l3 and a bone fragment which touched the nerve was removed.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8803465
• Report Number: 2031966-2019-00220
• Device Sequence Number: 327536
• Product Code: NKB
• UDI-Device Identifier: 00887517582218
• UDI-Public: 887517582218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: 13115540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention