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	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Via clinical study, it was reported that the patient was experiencing heterotopic ossification at the index levels 36 months after their index procedure at c4/5 and c5/6 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.
Additional Manufacturer Narrative
There was no product returned and there was no product problem identified.The devices remain 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.
Additional Manufacturer Narrative
Duplicate of mfr: 2031966-2021-00170.All information previously recorded on mfr: 2031966- 2021-00170.
Event or Problem Description
Information was received via simplify disc level 2 retrospective study review that an index cervical procedure was completed at index level of c4/6 for patient (b)(6) on an unknown date.On their 36 month on (b)(6) 2021 it was reported that there was heterotopic ossification was observed.There was no treatment plan given.

• Brand Name: SIMPLIFY® CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 13361945
• Report Number: 2031966-2022-00018
• Device Sequence Number: 19742368
• Product Code: MJO
• UDI-Device Identifier: 00843285101952
• UDI-Public: 843285101952
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 3451
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose