MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C SK, LARGE DEEP, 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSLD6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a simplify device at c4-5.It was found that the device had migrated posteriorly into the canal resulting in a dural tear and a csf leak.The surgeon removed the simplify device and replaced it with a prodisc c sk device on (b)(6) 2025.The pdc sk device did not resolve the csf leak so the implant was removed on (b)(6) 2025 and the patient was fused.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a simplify device at c4-5.It was found that the device had migrated posteriorly into the canal resulting in a dural tear and a csf leak.The surgeon removed the simplify device and replaced it with a prodisc c sk device on (b)(6) 2025.The pdc sk device did not resolve the csf leak so the implant was removed on (b)(6) 2025 and the patient was fused.A dhr review found no anomalies associated with this 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 implant was returned following the removal surgery and will be evaluated using exponents approved prodisc c evaluation protocol.The report will be issued under (b)(4).No pre-removal imaging was provided.There were no anomalies identified during the complaint investigation, the removal was completed as the pdc sk device did not resolve the csf leak.The submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C SK, LARGE DEEP, 6MM
• 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: 23770906
• Report Number: 3007494564-2025-00138
• Device Sequence Number: 9667485
• Product Code: MJO
• UDI-Device Identifier: 00843193113955
• UDI-Public: (01)00843193113955(17)290531(10)2024-0511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: PDSLD6
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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: 50 YR
• Patient Sex: Male