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

Model Number	09.820.055S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient underwent a pdc implantation at c5-7.The implantation was completed on (b)(6) 2022.Following the procedure the patient is paralyzed.Several attempts were made to gather additional information but it is unknown what occurred intraoperatively.A review of the device history records found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is at the lowest possible level of improbable.A review of the risk documentation found that the risks associated with the complaint are identified and have been mitigated to a level where the benefits outweigh the risks.Device evaluation could not be completed as the implant remains within the patient.The investigation found no anomalies associated with the complaint.The cause for the patient's condition is unknown.This report is for 1 of 2 devices involved in this event.
Event or Problem Description
It was reported that a patient underwent a pdc implantation at c5-7.The implantation was completed on (b)(6) 2022.Following the procedure the patient is paralyzed.Several attempts were made to gather additional information but it is unknown what occurred intraoperatively.
Additional Manufacturer Narrative
Addition of udi number.
Event or Problem Description
Update to add udi number to report.

• Brand Name: PRODISC C US IMPLANT LARGE-DEEP 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 15819361
• Report Number: 3007494564-2022-00051
• Device Sequence Number: 17916913
• Product Code: MJO
• UDI-Device Identifier: 00843193112842
• UDI-Public: 00843193112842
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 12/31/2025
• Device Model Number: 09.820.055S
• Device Lot Number: 2021-0988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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: Disability
• Patient Age: 52 YR
• Patient Sex: Female