MAUDE Adverse Event Report: Centinel Spine, LLC Prodisc C Vivo US Implant Extra Large 6mm; Prosthesis, Intervertebral Disc

Model Number	PDVXL6
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a prodisc c vivo device on (b)(6)2025.It is unknown if the patient experienced any symptoms, however, imaging showed that the implant had migrated.The implant was removed on (b)(6)2026 and the patient was fused.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.A patient was implanted with a prodisc c vivo device on (b)(6)2025.It is unknown if the patient experienced any symptoms, however, imaging showed that the implant had migrated.The implant was removed on (b)(6)2026 and the patient was fused.A dhr review found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outline 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 harms.The implant was not returned following removal surgery therefore, no device evaluation could be completed.Imaging was provided that showed the device had migrated.There were no anomalies identified during the complaint investigation.The removal was completed due to implant migration.The submission is 1 of 1 devices involved in this event.

• Brand Name: Prodisc C Vivo US Implant Extra Large 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 Exton; 240 sierra drive; suite 100; exton PA 19340
• Manufacturer Contact: jasmine carrillo ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 50305536
• Report Number: 3007494564-2026-00069
• Device Sequence Number: 10134929
• Product Code: MJO
• UDI-Device Identifier: 00843193113801
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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
• Device Model Number: PDVXL6
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0254
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: 62 YR
• Patient Sex: Male