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

Model Number	PDVL5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was implanted with a prodisc c vivo device at c5-6 on (b)(6) 2025.Patient was experiencing ongoing pain and an mri was ordered.Mri showed a possible hematoma of unknown origin; the surgeon was uncertain about the hematoma due to device artifact on the mri.Surgeon removed the implant on (b)(6) 2025 and replaced it with a keeled implant.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc c vivo device at c5-6 on (b)(6) 2025.Patient was experiencing ongoing pain and an mri was ordered.Mri showed a possible hematoma of unknown origin; the surgeon was uncertain about the hematoma due to device artifact on the mri.Surgeon removed the implant on (b)(6) 2025 and replaced it with a keeled implant.A dhr review found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that 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.Additionally, no imaging was provided.The removal was completed due to ongoing pain and a possible hematoma.The submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT 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 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: 21510209
• Report Number: 3007494564-2025-00033
• Device Sequence Number: 4448926
• Product Code: MJO
• UDI-Device Identifier: 00843193113733
• UDI-Public: (01)00843193113733(17)281130(10)2023-1499
• 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: 2025
• 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): 03/03/2025

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: PDVL5
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: 33 YR
• Patient Sex: Male