MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT LARGE DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.055S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Neck Pain (2433)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter indicates the prodisc c device was removed due to neck pain and radiculopathy.It was not known whether the prodisc c device was causing or contributing to these symptoms, so a conservative assessment determined this may be a reportable adverse event requiring an mdr.The removal was completed successfully and replaced with an unknown device or therapy.The explanted devices were retrieved and sent for analysis at a third party laboratory.Dhr review did not find any issues during manufacturing which may have caused or contributed to the event.The risk assessment identified the applicable risks and determined they were acceptable.Device evaluation has yet to be completed by the third party laboratory.If any device malfunctions or problems are found during the evaluation, this submission may be updated.As of this submission there has been no indication of a device malfunction or use error resulting in this adverse event.The investigation could not determine a cause for this event.This submission is for 2 of 2 prodisc c devices involved in this event.
Event or Problem Description
Patient was diagnosed/scheduled for prodisc c removal on an unknown date.Removal was to take place on (b)(6) 2021 due to neck pain and radiculopathy.There was no indication of device malfunction or device problems.It is unknown if the device was causing/contributing to the neck pain or radiculopathy.Prodisc c removal was successfully completed on (b)(6) 2021.The 2-level prodisc c construct was removed from c5/6 and c6/7.There was no indication what the devices were replaced with.

• Brand Name: PRODISC C US IMPLANT LARGE DEEP 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12051409
• Report Number: 3007494564-2021-00055
• Device Sequence Number: 15819217
• Product Code: MJO
• UDI-Device Identifier: 00843193112842
• UDI-Public: 00843193112842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 09.820.055S
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR