MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C VIVO US IMPLANT LARGE-DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVLD5
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was implanted with a pdc vivo implant at c6-7 on (b)(6) 2025.At the two month follow up it was found that the implant was in a kyphotic position and at the four month follow up it was found that the implant had migrated posteriorly.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc vivo implant at c6-7 on (b)(6) 2025.At the two month follow u,it was found that the implant was in a kyphotic position and at the four month follow up it was found that the implant had migrated posteriorly.A dhr review found no anomalies associated 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 documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The device remains implanted within the patient therefore no device evaluation could be completed.Imaging was provided to show the migration or loosening of the implant.There were no anomalies identified during the complaint investigation, the reason for the implant migration is unknown.The submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT LARGE-DEEP 5MM
• 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: 23555964
• Report Number: 3007494564-2025-00124
• Device Sequence Number: 10114560
• Product Code: MJO
• UDI-Device Identifier: 00843193113764
• UDI-Public: (01)00843193113764(17)300228(10)2025-0339
• 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
• 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): 11/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDVLD5
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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
• Patient Age: 44 YR
• Patient Sex: Male