MAUDE Adverse Event Report: CENTINEL SPINE PRODISC L PE INLAY M 10; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-PT10S

Device Problem Expulsion (2933)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that the prodisc l poly inlay had "popped out" and unlocked from the inferior endplate, premature poly wear, expulsion.Patient was implanted with a prodisc l device at l4-5 on (b)(6) 2021.Patient was completely asymptomatic until 2-3 months ago.Presented with new complaints of lower back pain, adjacent level pathology was ruled out.It was found that the inlay was expelled.Surgeon was treating conservatively and no additional treatment has been scheduled.

Manufacturer Narrative

It was reported that a patient was implanted with a prodisc l device at l4-5 on (b)(6) 2021.Patient was completely asymptomatic until 2-3 months ago.Presented with new complaints of lower back pain, adjacent level pathology was ruled out.It was found that the inlay was expelled.Surgeon was treating conservatively and no additional treatment has been scheduled.It was determined that the complaint was an mdr reportable due to device malfunction.Three devices were involved in the complaint, the prodisc l superior plate, the poly inlay, and the inferior plate.A review of the dhr for the poly inlay was completed and no anomalies associated with the complaint were identified.Complaint trending found that the rate of complaints to be within the poc indicated in the risk assessment.A review of the risk assessment found that the risks are identified and mitigated to a level where the benefits outweigh the risk.Device evaluation could not be completed as the pdl device remains implanted within the patient.This report is for 3 of 3 devices involved in this event.

• Brand Name: PRODISC L PE INLAY M 10
• 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: 16502114
• MDR Text Key: 311361513
• Report Number: 3007494564-2023-00010
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PDL-M-PT10S
• Device Lot Number: 2020-1450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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 Age: 37 YR
• Patient Sex: Male