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

Model Number	4061647P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No alleged device problem was identified so no device was returned for evaluation as well no images or lab reports provided so the complaint could not be confirmed.Review of the reported event identified the patient experienced postoperative right leg pain and swelling due to an identified deep vein thrombosis (dvt).No information provided to suggest the source of the dvt so no root cause could be determine however, this may have been the result of an underlying patient condition, a result of the patients injury or the result of surgical trauma, dvt is a well known complication of surgery and not considered the direct result of a nuvasive device.No additional investigation can be completed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: potential adverse events and complications potential adverse effects resulting from use of the cohere cervical interbody fusion device include, but are not limited to, the following.Hematoma or thrombosis." "warnings, cautions and precautions.The cohere cervical interbody fusion device should be used only by those physicians who have been trained in the appropriate, specialized procedures.Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome." "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." 9402598-en f-01/2021.
Event or Problem Description
The event was identified during a review of the cervical interbody pmcf study, the report identified that on (b)(6) 2024 a patient underwent a two level anterior cervical discectomy fusion and procedure at c4/5 and c5/6.On (b)(6) 2024 the patient experienced right leg pain and swelling and was readmitted, diagnosed and treated for deep vein thrombosis of the right femoral vein.No additional information provided.

• Brand Name: NUVASIVE COHERE CERVICAL 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: whitney ginter ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 20487403
• Report Number: 2031966-2024-00269
• Device Sequence Number: 3615099
• Product Code: ODP
• UDI-Device Identifier: 00887517056313
• UDI-Public: 887517056313
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K231735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 4061647P2
• 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: 10/18/2024
• Initial Report FDA Received Date: 10/18/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female