MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE MODULUS-C INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	6793001P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event was identified during a review of the cervical interbody pmcf study, the report identified that on (b)(6) 2022 a patient underwent a two level anterior cervical discectomy fusion procedure at c4/5 and c5/6.On (b)(6) 2022 radiographic imaging noted a slight subsidence of subjects c5/c6 interbody.At the same follow up, the subject indicated decreased sensation of the first 3 fingers of the right hand.Subject will continue follow ups and pi ordered an emg.No revision is planed and the patient will continue to be monitored.
Additional Manufacturer Narrative
No device was returned for evaluation as it is still in-situ and no radiographs were provided so the complaint was not confirmed.The patients bone quality is unknown.The patient post operative physical activity is unknown.Review of the reported event identified that 5 months postoperative of a interbody placement subsidence was observed and finger numbness experienced.No root cause could be determined with the information provided although implant selection and placement, bone quality, space preparation, infection as well as postoperative excessive physical activity are possible cause or contributors.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-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: 1.Infection, local to the operative site.2.Signs of local inflammation.3.Patients with known sensitivity to the materials implanted.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 include: early or late infection.Spinal cord or peripheral nerves.Loss of sensory and/or motor function." "potential risks identified with the use of this system, which may require additional surgery, include.Neurological, vascular or visceral injury.Metal sensitivity or allergic reaction to a foreign body.Tissue reactions including macrophage and foreign body reactions adjacent to implants.Infection.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).Pain, discomfort or abnormal sensations due to the presence of the device.Nerve damage due to surgical trauma.Paralysis." "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.The modulus-c interbody devices are required to be used with an anterior cervical plate as the form of supplemental fixation.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." "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." "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.5.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 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-C INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• 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: 20485980
• Report Number: 2031966-2024-00267
• Device Sequence Number: 4105575
• Product Code: ODP
• UDI-Device Identifier: 00887517940933
• UDI-Public: 887517940933
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223731
• 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): 10/18/2024

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: 6793001P2
• 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: 10/18/2024
• Initial Report FDA Received Date: 10/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female