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

Model Number	PDVLD6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient (40 years, male) was implanted with two prodisc c vivo devices at c5-6 and c6-7 on (b)(6) 2025.At three months post implantation the patient was still experiencing neck pain.The surgeon removed both devices and completed an acdf at c5-7 on (b)(6) 2026.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc c vivo devices at c5-6 and c6-7 on (b)(6) 2025.At three months post implantation the patient was still experiencing neck pain.The surgeon removed both devices and completed an acdf at c5-7 on (b)(6) 2026.A dhr review found no anomalies identified 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 documents found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The implants were returned following the removal surgery, and will be evaluated using exponents approved prodisc c evaluation protocol.The reports will be issued under pdcv-0040 and pdcv-0041.No pre-removal imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed due to ongoing pain, therapy device not effective.This submission is 2 of 2 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT 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: 24506273
• Report Number: 3007494564-2026-00017
• Device Sequence Number: 9870453
• Product Code: MJO
• UDI-Device Identifier: 00843193113771
• UDI-Public: (01)00843193113771(17)290630(10)2024-0686
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2026
• 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): 03/03/2026

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: PDVLD6
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/04/2026
• 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: 40 YR
• Patient Sex: Male