MAUDE Adverse Event Report: NUVASIVE, INC. SIMPLIFY® CERVICAL ARTIFICIAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	2-4-CE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned and there was no product problem identified.The device remains in-situ with no reported plans to remove or revise, and no other treatments or actions have been taken in relation to the reported event.A definitive cause of the reported ossification cannot be determined.Label review: ".There is a risk of heterotopic ossification associated with artificial cervical discs which could lead to reduced cervical motion or fusion at either the treated level(s) or adjacent levels." if additional information becomes available, a supplemental report will be filed.
Event or Problem Description
Via clinical study, it was reported that the patient was experiencing heterotopic ossification at the index levels 48 months after their index procedure at c5/6 and c6/7 with simplify implants.There has been no reported treatment for the reported condition and there are no reported plans to remove or revise the implants.No additional information is available.Report 1 of 2.

• Brand Name: SIMPLIFY® CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12888668
• Report Number: 2031966-2021-00168
• Device Sequence Number: 4571660
• Product Code: MJO
• UDI-Device Identifier: 00843285101952
• UDI-Public: 843285101952
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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: 2-4-CE
• Device Lot Number: 3055
• 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: 11/17/2021
• Initial Report FDA Received Date: 11/29/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose