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

Model Number	PDVXL5
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a 2-level prodisc c vivo device below a fusion at c5-7 on (b)(6) 2026.There was no report of patient pain or other symptoms.However, imaging showed that the implant at c5-6 had migrated anteriorly.The implant was removed from c5-6 on (b)(6) 2026 and replaced with a prodisc c nova device.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.A patient was implanted with a 2-level prodisc c vivo device below a fusion at c5-7 on (b)(6) 2026.There was no report of patient pain or other symptoms.However, imaging showed that the implant at c5-6 had migrated anteriorly.The implant was removed from c5-6 on (b)(6) 2026 and replaced with a prodisc c nova device.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 harms.The implant was not returned following the surgery; however, imaging was provided that showed that the implant had migrated anteriorly.There were no anomalies identified during the complaint investigation.The removal was completed due to implant migration.The submission is 1 of 1 device involved in this event.

• Brand Name: Prodisc C Vivo US Implant, Extra Large, 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 Exton; 240 sierra drive; suite 100 PA 19340
• Manufacturer Contact: jasmine carrillo ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 50783245
• Report Number: 3007494564-2026-00088
• Device Sequence Number: 9442831
• Product Code: MJO
• UDI-Device Identifier: 00843193113795
• UDI-Public: (01)00843193113795(17)300930(10)2025-1134
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/15/2026

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: PDVXL5
• Device Catalogue Number: N/A
• Device Lot Number: 2025-1134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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: 70 YR
• Patient Sex: Female