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

Model Number UNKNOWN

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neck Pain (2433)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient received a two level pdc implant approximately a year ago.The patient experienced radicular pain caused by inadequate decompression, although the surgeon stated that the implants perfect and structurally sound the decision was made to remove the implants.The removal was completed on (b)(6) 2022 and the patient was fused using a globus cage.Dhr review could not be completed as the implant information was not provided.Complaint trending found the rate of this type of complaint to be at a remote level.A review of the risk assessment found that the risks associated with this complaint are identified to an acceptable level.The devices were sent to exponent for evaluation under (b)(4).No anomalies were found during the investigation that related to the complaint.Inadequate decompression could be related to surgical technique or from improper implant sizing.This submission is 1 of 2 devices involved in this event.

Event Description

Surgeon had scheduled a two level prodisc c removal for (b)(6) 2022.Surgeon states that the implants are perfect and structurally sound, he indicated an inadequate decompression and radicular symptoms as the cause for removal.Second surgeon was the implanting surgeon, possibly a year ago.

• Brand Name: PRODISC C US IMPLANT X-LARGE
• 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
• MDR Report Key: 14167615
• MDR Text Key: 289754604
• Report Number: 3007494564-2022-00028
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2022
• 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: 62 YR
• Patient Sex: Male