MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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

Patient Problem Cyst(s) (1800)

Event Date 07/31/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been created from a clinical study review so no product returned for evaluation and no images were provided so the complaint cannot be confirmed.The review of the reported event identified developed to synovial cysts post-index procedure and unrelated to nuvasive devices, additionally adjacent segment and facet degeneration was observed and considered a continuation of pathology and the root cause of the reported event.No product problem was reported or identified, no additional investigation can be completed.Labeling review: "contraindications contraindications include, but are not limited to:.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include:.Tissue reactions including macrophage and foreign body reactions adjacent to implants.Degenerative changes or instability of segments adjacent to fused vertebral levels." "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 ensure that all components are ideally fixated prior to closure." "pre-operative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." 9402772-en k-2022-06.

Event Description

It was reported in a clinical study that a patient underwent an extreme lateral interbody fusion at l4/5 on (b)(6) 2021.An mri on (b)(6) 2022 showed l5/s1 moderate degenerative disc disease and severe bilateral degenerative facet disease with a 2 to 3 mm anterolisthesis of l5.Bilateral intraspinal synovial cysts measuring 6mm on the left and 7mm on the right, causing significant mass effect on bilateral s1 nerve roots.Treatment was conducted on (b)(6) 2023, an anterior lumbar interbody fusion at right l4/5 and l4/l5 removal of hardware and bilateral l5/s1 facet injections and esi injection at l5/s1.

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18521259
• MDR Text Key: 332952938
• Report Number: 2031966-2024-00028
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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
• Date Manufacturer Received: 12/21/2023
• 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): Required Intervention
• Patient Sex: Prefer Not To Disclose