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

Model Number	1181245P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the first part of a two part procedure was performed.The first stage was anterior column support using extreme anterior lumbar interbody fusion.At l4/5 another manufacturer's implant was utilized and at l1/4 and l5/s1 nuvasive implants were used.Post-op the patient reported right side pain.On (b)(6) 2021 radiographs taken revealed the implant at l3/4 migrated.On (b)(6) 2021 the second part of the procedure was conducted where posterior fixation was placed and additional radiographs still showed the migration of the implant at l3/4.On (b)(6) 2021 the patient reported no pain.No additional revision surgery is planned.
Additional Manufacturer Narrative
Product was not returned as product is still in-situ.Radiographs provided confirm the complaint.Review of the reported event identified the migration took place prior to the placement of the required fixation device and nuvasive devices were combined with another manufacturer's which is considered off-label use.The patient's post-op physical activity is unknown.Though no root cause could be determined the delay in posterior fixation, physical activity, implant selection, and combining nuvasive implants with another manufacturer's are all considered contributing factors.No revision surgery is planned and no additional investigation can be completed.Labeling review: ".Indications for use:modulus xlif interbody system the nuvasive modulus xlif interbody system is indicated for intervertebral body fusion of the spine in skeletally mature patients.The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.When used with or without modulus xlif internal fixation, the system is intended for use with supplemental spinal fixation system cleared by the fda for use in the thoracolumbar spine." ".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: bending, fracture or loosening of implant components, loss of fixation." ".Warnings, cautions 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.Additional care should be taken at the lower levels of the lumbar spine due to the obstruction of anatomical structures, such as the iliac crest and iliac vessels, surgical access for the subject device at the these levels may not be feasible.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." ".Compatibility: do not use the modulus interbody system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.".

• 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: 12797500
• Report Number: 2031966-2021-00153
• Device Sequence Number: 12159673
• Product Code: MAX
• UDI-Device Identifier: 00887517725943
• UDI-Public: 887517725943
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201692
• 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: 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: 1181245P2
• Device Lot Number: MI0737
• 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: 11/04/2021
• Initial Report FDA Received Date: 11/11/2021
• 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
• Patient Sex: Female