MAUDE Adverse Event Report: CENTINEL SPINE PRODISC L INFERIOR END PLATE MEDIUM 3-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-IP03S

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted with a prodisc l device at l5/s1 on (b)(6) 2022.The patient presented with significant pain and radiculopathy and required a walker to walk.X-ray images showed that the implant was off of midline.The pdl was removed on (b)(6) 2023 and replaced with a new prodisc l device.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints was within the levels defined in the risk documentation.A review of the risk documentation found that the harms associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation could not be completed as the implant was not returned following the removal.The pain and radiculopathy was caused by the implant off of midline, which was the cause for the pdl removal.This report is for 3 of 3 devices in this event.

Event Description

It was reported that a patient was implanted with a pdl implant at l5/s1 in louisiana a few months ago and presented with significant pain.Surgeon believes that she can be revised to another pdl.Removal surgery was completed on (b)(6)2023.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 3-STERILE
• 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: 16855489
• MDR Text Key: 314406684
• Report Number: 3007494564-2023-00024
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-IP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Sex: Female