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

Model Number	1181055P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 a patient underwent a extreme lateral interbody fusion procedure from l2 to l5.The surgery was completed with no issue but it was observed that the implanted vertebral spacer was misaligned at the l3/l4 level and posterior fixation was implanted as is.On a unknown date in november of 2023 it was reported the patient was experiencing back and lower limb pain.The patient visited the physician where images discovered further migration of the l3/4 cage.The images also revealed fusion had been achieved at l2/3, l4/5, but not at l3/4.A revision surgery was reported to have occurred on (b)(6) 2023 but despite requesting no additional information could be obtained regarding the revision.The patient post op activity levels or whether they experienced any accidents or falls is unknown but they were reported to have fused on all level except the migrated level of the construct.
Additional Manufacturer Narrative
The device was not received by nuvasive although radiographs provided confirmed the event.Review of the reported event identified the surgeon failed to optimally place the interbody at l3-4.The patient post op activity levels or whether they experienced any accidents or falls is unknown.Examination of the provided radiographs confirmed the index placement of the interbody at l3-4 was left protruding approx.5mm out on the left side of the vertebral margin.Additional evaluation including pre-revision radiographs identified the interbody at l2-3 was later protruding approx.3mm out of the left side confirming the post-operative migration at that level.The interbody's at l3-4 and l4-5 appear to have remained stable as no change in position was identified.The root cause of the reported event appears to be the result of the reported poor interbody placement during index procedure and subsequent uneven loading.No additional investigation can be completed.Manufacturing review: review of the device history record notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "contraindications contraindications include, but are not limited to.4.Patients who are unwilling to restrict activities or follow medical advice.5.Patients with inadequate bone stock or quality.6.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.Infrequent operative and postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union." "warnings, cautions and precautions the subject device is intended for use only as indicated.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.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." ".Based on fatigue testing results, when using the modulus interbody system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system." "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." "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." "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." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." (b)(6).

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: 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: 18377564
• Report Number: 2031966-2023-00292
• Device Sequence Number: 12704366
• Product Code: MAX
• UDI-Device Identifier: 00887517725905
• UDI-Public: 887517725905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/21/2023

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: 1181055P2
• Device Lot Number: ML02545
• 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: 11/28/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Age: 47 YR
• Patient Sex: Male