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

Model Number	67940036P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Even though root cause cannot be confirmed, a review of event description and provided radiographs confirmed no supplemental fixation was added as recommended per instructions for use.Labeling review: 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), loss of fixation, pain, discomfort or abnormal sensations due to the presence of the device." warnings, cautions and precautions ".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." 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.".
Event or Problem Description
On (b))(6) 2020, patient underwent a cervical spine procedure where a cervical spacer cage was used stand alone and no additional fixation or plating was utilized.Patient had swallowing pain after the index procedure.On (b))(6) 2020, it was discovered there was a dislocation of the cervical spacer in between the c3 and c4 levels.A revision procedure was performed on (b))(6) 2020, where the migrated implant was replaced with another manufacturers implant.The patient is reported to be doing well post revision procedure.
Event or Problem Description
New or updated information found on sections: d7,h6, h10.
Additional Manufacturer Narrative
The product was received and no product functioned as intended, the radiographs provided were utilized and the complaint was confirmed.The root cause of the issue is related to off label use as no additional fixation devices were utilized which testing has show leads to migration of the cage.The surgeon was informed of fixation requirements.No additional investigation required.Labeling review: ".Indications for use: the nuvasive modulus-c interbody system is indicated for intervertebral body fusion of the spine in skeletally mature patients.The modulus-c interbody system is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, ct, mri), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2 - t1.The system is intended to be used with supplemental fixation.".

• Brand Name: NUVASIVE MODULUS-C INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10287443
• Report Number: 2031966-2020-00146
• Device Sequence Number: 1074320
• Product Code: ODP
• UDI-Device Identifier: 00887517959607
• UDI-Public: 887517959607
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K172676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 67940036P2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR