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

Model Number 09.820.025S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted with two prodisc c implants that were placed at c5-6 and c6-7 on (b)(6) 2022.The patient began experiencing pain in their right arm.The decision was made to remove the pdc implant as it was needed to remove the disc from the foramen.The patient had the pdc removed on (b)(6) 2023, and a new prodisc c implant was placed.The surgeon did not believe that there was any problem or malfunction of the implant.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels in the risk documentation.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation is being completed by exponent based on their standard pdc evaluation protocol.There were no anomalies related to the complaint found during the investigation.The removal was completed due to the patient's arm pain and the need to remove the disc from the foramen.This report is for 2 of 2 devices involved in this event.

Event Description

It was reported that a patient was implanted with two prodisc c devices on (b)(6) 2022 at c5-6 and c6-7.The patient had pain in their right arm which was found to be caused by the disc being positioned in the foramen.A pdc removal was completed on (b)(6) 2023 and a new pdc device was placed.It was not reported which level was removed and replaced and x-ray images were not provided.

• Brand Name: PRODISC C US IMPLANT MEDIUM 5MM
• Type of Device: 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: 16579760
• MDR Text Key: 311653974
• Report Number: 3007494564-2023-00015
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09.820.025S
• Device Lot Number: 2021-0990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male