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

Model Number	2-5-CE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
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.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 experienced heterotopic ossification at the c6/7 index level of a simplify implant.No current treatment is being performed for the heterotopic ossification and there is no reported plan to remove or revise the simplify implant.No additional information is available.

• 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: 13643000
• Report Number: 2031966-2022-00048
• Device Sequence Number: 11878606
• Product Code: MJO
• UDI-Device Identifier: 00843285101976
• UDI-Public: 843285101976
• 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
• Device Implanted Year: 2016
• 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): 03/01/2022

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: 2-5-CE
• Device Lot Number: 2905
• 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: 02/03/2022
• Initial Report FDA Received Date: 03/01/2022
• 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