MAUDE Adverse Event Report: NUVASIVE, INCORPORATED COROENT TI-C SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6130823
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent a mas procedure from l5-s.During the procedure two spacer cages were placed and the procedure was completed without issue.The following day a post-operative x-ray confirmed the implants had good placement.During a follow up on (b)(6) 2021 the patient reported to have been feeling ongoing pain.Another mri occurred which showed the right sided cage had migrated posterior and was protruding.On (b)(6) 2021 a revision case occurred.During the revision the migrated cage was replaced with a new one and the rest of the surgery was completed with no issue.
Additional Manufacturer Narrative
No product was returned due to the facilities infection control protocol but radiographs were provided confirming the alleged device migration.It was noted the patient was obese but were reported to have been compliant with post-operative physical restrictions.The root cause could not be determined.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 bending, fracture or loosening of implant component(s)." "warnings, cautions and precautions - correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." "based on fatigue testing results, when using the coroent xl interfixated system, the physician/ surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system." "post-operative warnings - 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.".

• Brand Name: COROENT TI-C SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; 92121 CA 92121
• MDR Report Key: 12634163
• Report Number: 2031966-2021-00143
• Device Sequence Number: 3452364
• Product Code: MAX
• UDI-Device Identifier: 00887517597137
• UDI-Public: 887517597137
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 6130823
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 10/14/2021
• 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: Required Intervention
• Patient Weight: 140