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

Model Number	PDL-M-IP03S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/08/2025
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 a prodisc l device at l5-s1 on (b)(6) 2024.The patient had on-going pain with no malfunction of the device.The implant was removed on (b)(6) 2025 and the patient was fused.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found 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.No device evaluation could be completed as the hospital did not release the implant following the removal surgery.No imaging was provided but the surgeon stated that he didn't believe the patient's symptoms were caused by the device.No anomalies were identified during the complaint investigation.The removal was completed due to the patient's ongoing pain.The submission is 3 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2024.The patient had on-going pain with no malfunction of the device.The implant was removed on (b)(6) 2025 and the patient was fused.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 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): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 21167807
• Report Number: 3007494564-2025-00009
• Device Sequence Number: 4603780
• Product Code: MJO
• UDI-Device Identifier: 00843193114969
• UDI-Public: (01)00843193114969(17)290131(10)2023-0659
• 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: 2024
• Device Explanted Year: 2025
• 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): 01/15/2025

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-M-IP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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: 43 YR
• Patient Sex: Female