MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE COROENT THORACOLUMBAR SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	5485540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned, but image provided confirmed the complaint.The patient's post-op physical activity is unknown and it is unknown if the patient suffered a fall.The patient's bone quality is unknown.Review of the provided radiograph identified the cage at l2/3 is protruding approximately 3mm beyond the disc margin on the right side although flush with the large marginal osteophytes under the plate.Additionally the two plate screws are not fully seated in the plate and do not appear to be engaging the lock mechanism and approimately 2mm backed out.Additional observation possible contact between plate screw and previously placed adjacent level posterior pedicle screws noted.No definitive root cause can be determined however review of the information provided identified the large lateral osteophytes obstructed proper plate placement allowing interbody migration, load shifting, and screw back out and likely the result of surgical technique and anatomical challenges of the patient.Note excessive post-op physical activity may be a possible cause or contributor.No additional investigation can be completed.Labeling review: "contraindications contraindications include, but are not limited to:.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.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).Decrease in bone density due to stress shielding, degenerative changes or instability of segments adjacent to fused vertebral levels, malalignment of anatomical structures (i.E.Loss of normal spinal contours or change in height)." "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.Care should be taken to ensure that all components are ideally fixated prior to closure." "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.Care should be used during surgical procedures to prevent damage to the device(s) 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 to 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." 9401854-en j-2022-06.H3 other text : no product returned.
Event or Problem Description
On (b)(6) 2023 a patient underwent an extreme lateral interbody fusion at l2/3.On (b)(6) 2024 the patient underwent a revision surgery due to the screws becoming loose (200073943) and cage migration (200073944).The surgeon removed them and tamped the cage in.He also extended up two levels.No additional injuries reported.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR 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: 18583729
• Report Number: 2031966-2024-00035
• Device Sequence Number: 12890975
• Product Code: MAX
• UDI-Device Identifier: 00887517250193
• UDI-Public: 887517250193
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 01/25/2024

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: 5485540
• 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: 01/05/2024
• Initial Report FDA Received Date: 01/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1221045P2; 1941108P2
• Patient Sex: Female