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	Limb Pain (4836)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc c vivo implant at c4/5 on (b)(6) 2024.The patient was experiencing right arm pain and it was found that the implant had migrated anteriorly.Implant was used off label and was placed on top of several fused levels.The surgeon removed the implant and fused the patient on (b)(6) 2024.A review of the dhr 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.A device evaluation could not be completed as the implant was not returned following the removal surgery.Imaging was provided that showed the implant migration.The removal was completed due to patient arm pain, the arm pain was caused by the implant migration.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c vivo implant at c4/5 on (b)(6) 2024.The patient was experiencing right arm pain and it was found that the implant had migrated anteriorly.Implant was used off label and was placed on top of several fused levels.The implant was removed and the patient fused on (b)(6) 2024.

• 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, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 21096328
• Report Number: 3007494564-2025-00002
• Device Sequence Number: 18309019
• Product Code: MJO
• UDI-Device Identifier: 00843193113672
• UDI-Public: (01)00843193113672(17)290831(10)2024-0816
• 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: 2024
• Device Explanted Year: 2024
• 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): 01/06/2025

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: 2024-0816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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: 58 YR
• Patient Sex: Female