MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE MODULUS XLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2104304P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was discarded at the user facility and could not be returned for evaluation.Patient's bone quality and post-op physical activity is unknown.The condition of the patient's facet joint prior to procedure is unknown.Though no root cause can be determined review of the reported information suggests excessive post-operative physical activity, implant selection/placement or the previously undiagnosed facet joint damage as possible causes or contributors.No additional investigation can be completed.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels, spinal cord or peripheral nerves.Potential risks identified with the use of this system, which may require additional surgery, include: pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma." "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.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.Care should be taken to ensure that all components are ideally fixated prior to closure." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".
Event or Problem Description
On (b)(6) 2021 a patient underwent a spinal procedure.On (b)(6) 2021 the patient was brought in due to increasing leg pain and a revision procedure took place where it was discovered that bone from the facet joint was impinging a nerve and the interbody migrated.The implant was removed and decompression was conducted.The patient is reportedly pain-free post-op.

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY 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: 12797619
• Report Number: 2031966-2021-00154
• Device Sequence Number: 12159801
• Product Code: MAX
• UDI-Device Identifier: 00887517881052
• UDI-Public: 887517881052
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 2104304P2
• Device Lot Number: ML1324
• Was Device Available for Evaluation?: No
• 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: 11/09/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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
• Patient Sex: Prefer Not To Disclose