MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	8595520
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation and no radiographs or images provided therefore the alleged product malfunction cannot be confirmed.Review of the provided information identified a possible malplacement of the screw and possible nerve impingement though no root cause could be determined.No additional investigation can be completed at this time.Labeling review: ".Warnings, and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications known to occur include: early or late infection which may result in the need for additional surgeries; damage to blood vessels; spinal cord or peripheral nerves, pulmonary emboli; loss of sensory and/or motor function; impotence; permanent pain and/or deformity." ".Preoperative warnings: 2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.6.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) 2019 a patient underwent spinal surgery on l3-s1.On (b)(6) 2019 the patient reported increased tailbone/right hip area pain.The patient stated their major complaint is pain in the right hip region and in their right buttocks region.The pain radiated into bilateral legs, but is worse on the right side.On (b)(6) 2020 the patient was treated with bilateral si joint injection.The surgeon reported the possibility of the pain could be caused by the right s2 alar screw.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 11339828
• Report Number: 2031966-2021-00032
• Device Sequence Number: 858713
• Product Code: MAX
• UDI-Device Identifier: 00887517322951
• UDI-Public: 887517322951
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K203201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8595520
• 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: 02/16/2021
• Initial Report FDA Received Date: 02/17/2021
• 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: Other; Required Intervention
• Patient Age: 70 YR