MAUDE Adverse Event Report: PRODISC L SUPERIOR END PLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Expulsion (2933)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Patient reported that he has a failed prodisc l at l4-5, the diagnostic imaging shows a protrusion of the inlay 5mm anterior from where it should be based on the marker positioning.Patient's surgeon has indicated that as a result their facets have been grinding more than normal and eroded the cartilage down to the bone.Surgeon is recommending that the implant be removed and to complete another fusion (already have one at l5-s1).

Manufacturer Narrative

Patient was implanted with a prodisc l device at level l4-5.Additionally, patient has a fusion at level l5-s1.Patient has been experiencing ongoing pain and inflammation due to grinding of his spinal facets that have eroded the cartilage.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 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 hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.A device evaluation could not be completed as the device remains implanted within the patient.It was confirmed that the poly inlay had expulsed.No anomalies were identified during the complaint investigation and the cause for the expulsion is unknown.This report is for 1 of 3 devices involved in this event.

• Brand Name: PRODISC L SUPERIOR END PLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 18108030
• MDR Text Key: 328276295
• Report Number: 3007494564-2023-00061
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Sex: Male