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

Model Number	13114545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation as no product malfunction was alleged.The root cause cannot be determined however the reported event suggests inadvertent contact with implant or instrumentation during index procedure.No additional investigation can be completed.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: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury ,pain, discomfort or abnormal sensations due to the presence of the device." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
On (b)(6) 2021 a spinal procedure was conducted at t9/s2, l3 was skipped and it was reported competitor's hardware was used.An osteotomy was performed at l3.Post-op a hematoma was discovered near left l3/4 that was causing paralysis.On (b)(6) 2021 a revision surgery was conducted to remove the hematoma.During the revision surgery the left rod was removed then re-installed and the lock screws were replaced.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11914716
• Report Number: 2031966-2021-00074
• Device Sequence Number: 14302646
• Product Code: NKB
• UDI-Device Identifier: 00887517581945
• UDI-Public: 887517581945
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 13114545
• Device Lot Number: SA0947
• 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: 05/12/2021
• Initial Report FDA Received Date: 06/01/2021
• 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
• Patient Age: 68 YR