MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L SUPERIOR PLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l device in 2010 at l5-s1.It was found that the poly inlay had expulsed anteriorly.It was unknown if the patient is symptomatic.No revision has been scheduled at this time.A review of the dhrs could not be completed as the part numbers and lot numbers were not provided and could not be determined during the course of the investigation.Complaint trending found the rate of complaints to be within the levels outlined 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 clinical benefits outweigh the risks.A device evaluation could not be completed as the device remains implanted within the patient.There were no anomalies identified during the investigation related to the complaint.The reason for the inlay expulsion is unknown.Submission is 1 of 3 devices involved in this event.

Event Description

A patient was implanted with a prodisc l device in 2010 at l5-s1.It was found that the poly inlay had expulsed anteriorly.It was unknown if the patient is symptomatic.No revision has been scheduled at this time.

• Brand Name: PRODISC L SUPERIOR PLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 18911861
• MDR Text Key: 337765454
• Report Number: 3007494564-2024-00022
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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