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

Model Number	67940002P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was discovered during the investigation of complaint (b)(4).On a (b)(6) 2021 a patient underwent an anterior cervical procedure from c5 to c7.The procedure was completed without incident.On a (b)(6) 2022 date it was discovered during a post-op follow up x-ray noted inferior/superior subsidence of the interbody¿s at c5-6 and c6-7 as well as the identified pseudoarthrosis (radiolucency) at the screw to bone interface at c5, c6 and c7.The patient was experiencing no adverse effects as a consequence of the issue and no revision is planned.2 of 2.
Additional Manufacturer Narrative
No product was returned as it still in-situ, but images provided confirmed the complaint.The patient's bone quality and postoperative physical activity are unknown.Review of the provided radiographs identified inferior/superior subsidence of the interbody¿s at c5-6 and c6-7 as well as pseudoarthrosis (radiolucency) at the screw to bone interface at c5, c6 and c7.The radiographs also showed a focal kyphosis at the c4-c5 level creating contouring challenges where there appears to be insufficient plate to bone interface leaving a gap between the plate and the vertebral body.The root cause of the reported event is considered the result of patient related factors as poor bone quality resulting in subsidence of all three vertebral bodies as well as a lack of bone growth at the screw interfaces and the noted focal kyphosis creating fixation challenges lead to increased loading, subsidence and screw back out.No additional investigation required.Manufacturing review: review of the device history records notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "contraindications 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." "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: bending, fracture or loosening of implant component(s) ,loss of fixation nonunion or delayed union, decrease in bone density due to stress shielding." "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.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." ".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." "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." "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 +1-800-475-9131.You may also email: info@nuvasive.Com." (b)(4).H3 other text : left in-situ.

• 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17440182
• Report Number: 2031966-2023-00154
• Device Sequence Number: 19511047
• Product Code: ODP
• UDI-Device Identifier: 00887517959003
• UDI-Public: 887517959003
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K223731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: 67940002P2
• 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: 08/01/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 18008315 PLATE SCREWS; 18009234 PLATE
• Patient Sex: Prefer Not To Disclose