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

Model Number	1225055P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent and extreme lateral interbody fusion with posterior fixation on (b)(6) 2024 at l3/5.On (b)(6) 2024 during a 2 month post-operative visit lumbar radiographs revealed a mild subsidence of the l3/4.It was indicated that the patient will be monitored and reviewed for revision.No information regarding a revision procedure has been obtained.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
Product is still in-situ and could not be evaluated.No radiographs or images were provided to confirm the complaint.Information regarding the patient's bone quality/bone density was not provided for review.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality." potential adverse events and complications: as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.The treatment of multilevel degenerative scoliosis may be associated with a lower interbody fusion rate compared to one- and two-level interbody fusions.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".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: 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.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as 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.".

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 20056510
• Report Number: 2031966-2024-00209
• Device Sequence Number: 12927292
• Product Code: MAX
• UDI-Device Identifier: 00887517726865
• UDI-Public: 887517726865
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2024

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: 1225055P2
• 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: 07/29/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODULUS XLW, 10X22X60MM 15.
• Patient Age: 74 YR
• Patient Sex: Male