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

Model Number	PDL-M-SP03S
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 2 of 3 devices in this event.

• Brand Name: PRODISC L SUPERIOR END PLATE MEDIUM 3-STERILE
• Common Device Name: 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: 16855436
• Report Number: 3007494564-2023-00023
• Device Sequence Number: 20715107
• Product Code: MJO
• UDI-Device Identifier: 00843193114983
• UDI-Public: 00843193114983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PDL-M-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female