MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE® COHERE® THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6120308P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received as the involved device was disposed of at the user facility.Multiple radiographs were provided confirming alleged incident.Review of the reported event identified the patient attempted to climb through a window of her house suggesting that to be the root cause of the device migration.No additional investigation required.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: bending, fracture or loosening of implant component(s)." "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 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." device disposed of at facility.
Event or Problem Description
On (b)(6) 2021 a patient underwent a transforaminal lumbar interbody fusion procedure on l5-s1 of the spine and the procedure was completed without issue.During the patients seven week follow up appointment the patient reported they were having issues with right leg nerve pain although the stated they still felt much better than before the initial procedure.The patients status continued to be monitored.During a three month follow up appointment the patient reported they continued to have distal right l5 symptoms.While she stated the symptoms were continuing to improve she stated there was an incident where she locked herself out of her house and had to crawl through her window.During the process something occurred which she said aggravated her symptoms and the patient began attending physical therapy to help her pain.On a unknown date it early (b)(6) it was discovered the implanted cage at the l5-s1 level had migrated.On (b)(6) a revision occurred where the implant was explanted.The patient is doing well post revision.

• Brand Name: NUVASIVE® COHERE® THORACOLUMBAR INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14136492
• Report Number: 2031966-2022-00074
• Device Sequence Number: 6231819
• Product Code: MAX
• UDI-Device Identifier: 00195377034984
• UDI-Public: 195377034984
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/18/2022

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: 6120308P2
• 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: 03/24/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female