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	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with two pdl devices on (b)(6) 2024 at l4/5 and l5/s1, the device at l4/5 subsided less than a week later causing back pain.The surgeon then removed both devices and fused the patient on (b)(6) 2024.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two pdl devices at l4/5 and l5/s1 on (b)(6) 2024, less than a week later the device at l4/5 subsided causing back pain.The surgeon then removed both devices and fused the patient on (b)(6) 2024.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels 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 implants were not returned following the removal surgery.Provided imaging confirmed the implant subsidence.The implant removal was completed due to implant subsidence, a reason for the subsidence is unknown.The submission is 1 of 6 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: 21230104
• Report Number: 3007494564-2025-00010
• Device Sequence Number: 7578188
• Product Code: MJO
• UDI-Device Identifier: 00843193114983
• UDI-Public: (01)00843193114983(17)290731(10)2023-1340
• 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: 2024
• 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): 01/23/2025

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: 2023-1340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: 48 YR
• Patient Sex: Female