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

Model Number	5902931P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Chest Pain (1776); Pneumonia (2011); Tachycardia (2095); Back pain (4895)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was identified during a review of the lumbar interbody study, the report identified that on (b)(6) 2024 transforaminal lumbar interbody fusion at l5-s1 with bilateral posterior fixation l5-s1.On (b)(6) 2024 pulmonary embolism presented to the ed on (b)(6) 2024 with acute onset chest pain that radiates into the back pain was so severe patient took an oxycodone prior to ed arrival.On exam in ed, afebrile, tachypnea, sating 93% ra and ct showed small acute pe and right upper lobe, right lower lobe shows ground-glass changes with atelectasis concern for possible pulmonary infarct.Patient was admitted on heparin drip.Also concern for community acquired pneumonia based on ct and elevated wbc.Stable on discharge on (b)(6) 2024.
Additional Manufacturer Narrative
No device malfunction was alleged so no device was returned, no radiographs or lab reports provided so the complaint was not confirmed.Review of the reported event identified the patient presented to an emergency department with acute onset chest pain that radiates into the back pain, testing identified a small acute pulmonary embolism and the right upper lobe, right lower lobe shows ground-glass changes with atelectasis concern for possible pulmonary infarct.Patient was admitted on heparin drip.Also concern for community acquired pneumonia.The root cause is considered the result of patient related factors as no product malfunction was alleged or identified.The reported pulmonary embolism is identified in the device labeling as known possible complications and unrelated to the nuvasive device.No additional investigation required.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-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "contraindications contraindications include, but are not limited to.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 include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli." "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." "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." "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 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: 21578331
• Report Number: 2031966-2025-00038
• Device Sequence Number: 9467732
• Product Code: MAX
• UDI-Device Identifier: 00887517958419
• UDI-Public: 887517958419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171633
• 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): 03/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/03/2025
• Initial Report FDA Received Date: 03/11/2025
• 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
• Outcome Attributed to Adverse Event: Other; Other
• Patient Age: 51 YR
• Patient Sex: Male