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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a pdc vivo implant at level c4-5 on (b)(6) 2024.At a check up it was found that the implant had subsided and migrated anteriorly.No patient symptoms were reported.The surgeon plans to remove the implant and complete a posterior cervical fusion.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc vivo implant at level c4-5 on (b)(6) 2024.At a check up it was found that the implant had subsided and migrated anteriorly.No patient symptoms were reported.The surgeon plans to remove the implant and complete a posterior cervical fusion.A review of the dhr found no anomalies associated with the complaint.Complaint trending found out 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 complaint device remains in the patient until the date of the removal surgery which is planned but not completed.If the device is returned following the removal surgery an evaluation will be completed following exponent's approved prodisc c device evaluation protocol.No imaging was provided.No anomalies were identified during the complaint investigation.A removal will be completed due to implant migration and subsidence.A reason for the migration and subsidence is unknown.The submission is 1 of 1 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, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 21677872
• Report Number: 3007494564-2025-00035
• Device Sequence Number: 8210050
• Product Code: MJO
• UDI-Device Identifier: 00843193113672
• UDI-Public: (01)00843193113672(17)280731(10)2023-0905
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/21/2025

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: 2023-0905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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: 54 YR
• Patient Sex: Female