MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C VIVO XLARGE 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVXL5
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc vivo device at c4-5 and two pdc sk devices at c5-6 and c6-7 on (b)(6) 2024.It was found that the vivo implant had migrated anteriorally, the sk implant at c5-6 was kyphotic, and the sk implant at c6-7 had migrated posteriorally and subsided.A second surgeon recommended removing all three levels and fusing c6-7, and converting c4-5 and c5-6 to pdc original.No additional information was provided and it is unknown if the patient received any additional surgical intervention.A review of the dhrs 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 devices remain implanted within the patient.Imaging was provided that confirmed the implant migration and subsidence, and spinal kyphosis.There were no anomalies identified during the investigation related to the complaint.A reason for the migration, subsidence, and spinal kyphosis is unknown.The submission is 1 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a pdc vivo device at c4-5 and two pdc sk devices at c5-6 and c6-7 on (b)(6) 2024.It was found that the vivo implant had migrated anteriorally, the sk implant at c5-6 was kyphotic, and the sk implant at c6-7 had migrated posteriorally and subsided.A second surgeon recommended removing all three levels and fusing c6-7, and converting c4-5 and c5-6 to pdc original.No additional information was provided and it is unknown if the patient received any additional surgical intervention.

• Brand Name: PRODISC C VIVO XLARGE 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: 21326997
• Report Number: 3007494564-2025-00019
• Device Sequence Number: 8062839
• Product Code: MJO
• UDI-Device Identifier: 00843193113795
• UDI-Public: (01)00843193113795(17)290331(10)2024-0269
• 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
• 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): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDVXL5
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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
• Patient Age: 31 YR
• Patient Sex: Male