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

Model Number	PDL-M-SP03S
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a pdl implant at l5-s1 on (b)(6) 2025.Implant was removed on (b)(6) 2025 and the patient was fused.Implant was removed due to implant expulsion; no patient symptoms were provided.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdl implant at l5-s1 on (b)(6) 2025.Implant was removed on (b)(6) 2025 and the patient was fused.Implant was removed due to implant expulsion; no patient symptoms were provided.A dhr review could not be completed as the lot numbers were not provided and could not be determined during the course of the investigation.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 implant was not returned following the removal surgery as the patient had requested it, therefore no device evaluation could be completed.Pre-removal imaging did show that the implant was expulsed from the disc space.The removal was completed due to implant expulsion / migration.This report is for 1 of 3 devices involved in this event.

• Brand Name: PRODISC L SUPERIOR 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: 21510205
• Report Number: 3007494564-2025-00030
• Device Sequence Number: 19945626
• Product Code: MJO
• UDI-Device Identifier: 00843193114983
• UDI-Public: (01)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: 2025
• 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): 02/28/2025

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-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 55 YR
• Patient Sex: Unknown