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

Model Number	PDL-L-SP03S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc l devices at level l4-l5 and l5-s1 on (b)(6) 2024.The patient had complaints of on-going pain and requested that the implants be removed and that they be fused.Removal was attempted on (b)(6) 2025, however, the surgeon could not visualize the implant intraoperatively and the removal was not completed.No status update on the patient was provided.A dhr review found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The removal was not able to be completed as the device could not be visualized intraoperatively, therefore no device evaluation could be done.Additionally, no imaging of the devices was provided.No anomalies were identified during the complaint investigation.The removal was attempted due to patient on-going pain as the therapy devices were not effective.The submission is 4 of 6 devices involved in this event.
Event or Problem Description
A patient was implanted with two prodisc l devices at level l4-l5 and l5-s1 on (b)(6) 2024.The patient had complaints of on-going pain and requested that the implants be removed and that they be fused.Removal was attempted on (b)(6) 2025, however the surgeon could not visualize the implant intraoperatively and the removal was not completed.No status update on the patient was provided.

• Brand Name: PRODISC L SUPERIOR END PLATE LARGE 3-STERILE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): 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: 23524385
• Report Number: 3007494564-2025-00114
• Device Sequence Number: 10187258
• Product Code: MJO
• UDI-Device Identifier: 00843193114952
• UDI-Public: (01)00843193114952(17)290831(10)2024-0119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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-L-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 56 YR
• Patient Sex: Male