MAUDE Adverse Event Report: Centinel Spine, LLC Prodisc C Vivo US Implant, Medium, 5mm; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVM5
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a 2-level prodisc c vivo device on (b)(6) 2025.The patient reporting having neck pain.Imaging showed that the implant had migrated anteriorly and possible osteolysis.The implants were 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 2-level prodisc c vivo device on (b)(6) 2025.The patient reporting having neck pain.Imaging showed that the implant had migrated anteriorly and possible osteolysis.The implants were removed on (b)(6) 2026 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 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 devices were not returned following the removal surgery, therefore device evaluation could not be performed.Imaging was provided that showed the implants had migrated anteriorly.There no anomalies identified during the complaint investigation.The removal was completed due to implant migration.The submission is 1 of 2 devices involved in this event.

• Brand Name: Prodisc C Vivo US Implant, Medium, 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, che 8320 ; SZ 8320
• Manufacturer Contact: jasmine carrillo ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 50772989
• Report Number: 3007494564-2026-00085
• Device Sequence Number: 15808726
• Product Code: MJO
• UDI-Device Identifier: 00843193113672
• UDI-Public: (01)00843193113672(17)300228(10)2025-0262
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: PDVM5
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female