MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L POLY INLAY, LARGE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-L-PT10S

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted with a with a prodisc l implant at l5-s1, sometime in the (b)(6) of 2022.Approximately 6 months later, it was found that the poly inlay had slid anteriorly and the inlay was expulsed.A revision surgery was completed on (b)(6) 2023 to remove the old poly inlay and seat a new inlay within the pdl implant.A dhr review could not be completed as the part number and lot number were not provided and could not be determined from the information received as part of the investigation.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazard associated with this complaint is identified and mitigated to a level where the benefits outweigh the risks.Device evaluation could not be completed because although the poly inlay was returned it was very damaged from the removal process.It was confirmed that a revision took place due to poly inlay expulsion.No other anomalies associated with the complaint were found during the investigation.This report is for 1 of 3 devices involved in this event.

Event Description

Patient was implanted with a with a prodisc l implant at l5-s1, sometime in the (b)(6) of 2022.Approximately 6 months later, it was found that the poly inlay had slid anteriorly and the inlay was expulsed.A revision surgery was completed on (b)(6) 2023 to remove the old poly inlay and seat a new inlay within the pdl implant.

• Brand Name: PRODISC L POLY INLAY, LARGE
• 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 ; 4848878894
• MDR Report Key: 16426474
• MDR Text Key: 310049486
• Report Number: 3007494564-2023-00005
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PDL-L-PT10S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Date Manufacturer Received: 01/26/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male