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

Model Number 09.820.025S

Device Problems Malposition of Device (2616); Expulsion (2933)

Patient Problem Neck Pain (2433)

Event Date 10/04/2022

Event Type  Injury  

Event Description

A patient was implanted with a prodisc c implant on (b)(6) 2022.On (b)(6) 2022 the patient reported to the emergency room with extreme pain.Films were taken and showed implant expulsion.An emergency revision was completed and the patient was fused.

Manufacturer Narrative

It was reported that the patient was implanted with a prodisc c implant at c4-5 on (b)(6) 2022.On (b)(6) 2022, the patient began experiencing severe pain and reported to the emergency room.Films were taken and it was observed that expulsion of the implant had occurred.The patient was taken to surgery where the implant was removed and the patient was fused.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints to be within the rates defined in the risk documentation.The risk assessment found that the harms associated with the complaint are identified and mitigated to an acceptable level.A device evaluation could not be completed as the pdc implant was not returned for evaluation.The investigation found that this was the surgeon's first case and that no centinel spine representative was present.No indication of a malfunction of the implant was found.The complaint investigation outcome found that the revision was likely caused by the keel cut not being deep enough and/ or that the implant was placed too anteriorly.A centinel spine representative reached out to the surgeon to offer peer-to-peer training but the surgeon did not respond.The investigation outcome is determined to be surgical technique.This report is for 1 of 1 devices involved in this event.

• 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
• MDR Report Key: 15713808
• MDR Text Key: 302832561
• Report Number: 3007494564-2022-00047
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• 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?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention