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

Model Number	67940001P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Stenosis (2263); Neck Pain (2433)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation as no product dysfunction was alleged, no radiographs provided so the event could not be confirmed.The patient postoperative activity or whether a fall was experience is unknown.No lot code information was provided so a complete manufacturing review could not be completed.The root cause of the event could not be determined with the information provided although a continuation of pathology and or excessive postoperative physical activity is suspected as the cause of contributor.No additional investigation can be completed.Label review: "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: nonunion or delayed union.Degenerative changes or instability of segments adjacent to fused vertebral levels.Pain, discomfort or abnormal sensations due to the presence of the device." "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." "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.".
Event or Problem Description
This event was identified during a review of the cervical interbody pmcf study that noted a patient underwent a anterior cervical discectomy fusion (acdf) procedure on (b)(6) 2021 at c5-t1.On (b)(6) 2024 the patient was suffering from left tricep, bicep, and shoulder weakness and mri and emg revealed c6-c7 foraminal stenosis.On (b)(6) 2024 the patient underwent a left c6-c7 foraminotomy with no additional problems reported.

• Brand Name: NUVASIVE MODULUS-C INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 20080869
• Report Number: 2031966-2024-00216
• Device Sequence Number: 12680434
• Product Code: ODP
• UDI-Device Identifier: 00887517958983
• UDI-Public: 887517958983
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K223731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 67940001P2
• 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: 07/29/2024
• Initial Report FDA Received Date: 08/27/2024
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 89 KG