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

Model Number	5902931P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation as it is still in-situ, no radiographs were provided so the complaint could not be confirmed.Review of the reported event noted 21 days after placement the interbody's appeared in radiograph as subsided.The patient postoperative physical activity is unknown.No definitive root cause could be determined although subsidence is a known complication of spinal surgery and likely the result of poor bone quality, implant selection/placement and or excessive postoperative physical activity.No additional investigation can be completed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformance with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "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." "residual risks and potential side effects as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." "potential risks associated with general surgical procedures of this type include: bending, fracture or loosening of implant component(s), loss of fixation." "the residual risks identified with using the tlx interbody system can be grouped into the following categories.Postoperative implant malfunctions including implant fracture, and unstable construct (i.E., subsidence, implant expulsion) which may result in loss of correction, pain, new or worsened deformity, any of which may necessitate revision surgery." "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.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.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." "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." "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)(4).You may also email: info@nuvasive.Com." (b)(4) (b)(6) 2023.
Event or Problem Description
The event was identified during a review of the pmcf lumbar interbody study, the report identified that on (b)(6) 2022 a patient underwent a two level transforaminal lumbar interbody fusion procedure at l4/5 and l5/s1.On (b)(6) 2022 follow up radiographs noted subsidence of both interbody's (l4-5, l5-s1).No revision or treatment provided.

• Brand Name: NUVASIVE TLX 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: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 21149470
• Report Number: 2031966-2025-00008
• Device Sequence Number: 21106591
• Product Code: MAX
• UDI-Device Identifier: 00887517958419
• UDI-Public: 887517958419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171633
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 5902931P2
• 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: 01/09/2025
• Initial Report FDA Received Date: 01/14/2025
• 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
• Patient Age: 83 YR
• Patient Sex: Male