MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT XL INTERFIXATED SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6914260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned as no product malfunction was identified, no images were provided therefore the complaint cannot be confirmed.Patient's bone quality is unknown.It is unknown if the patient suffered a fall.Patient's post-operative physical activity is unknown.Though a definite root cause cannot be determined review of the complaint report suggests bone quality, patient physical activity, and implant selection and or placement as possible cause or contributors.No additional investigation can be completed.Contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality.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 orthopedic surgery.Decrease in bone density due to stress shielding." 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.Pre-operative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and or predispositions such as those addressed in the aforementioned contraindications should be avoided.Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.Device in-situ.
Event or Problem Description
It was reported on a clinical study that on (b)(6) 2022 a patient underwent an extreme lateral interbody fusion at l3/4.On (b)(6) 2022 the patient was seen in the emergency room for left sciatic pain.An mri showed a compression fracture at the superior endplate of l3, no apparent complications or dislodgement of hardware.At l5-s1 there was lateral disc herniation involving in compressing left l5 nerve root.Treatment was pain block injections.

• Brand Name: NUVASIVE COROENT XL INTERFIXATED SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15807690
• Report Number: 2031966-2022-00256
• Device Sequence Number: 5747255
• Product Code: MAX
• UDI-Device Identifier: 00887517392183
• UDI-Public: 887517392183
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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: 6914260
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male