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

Model Number	PDVL5
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with two prodisc c vivo implants on (b)(6) 2023.Patient experienced a burning sensation and pain.It was determined that the patient had a nickel allergy.The implants were removed on (b)(6) 2024 and replaced with simplify ctdr.It was found after removal that a device culture determined the presence of an infection.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc c vivo implants on (b)(6) 2023 at levels c5-6 and c6-7.After implantation patient experienced burning sensation and pain.It was stated that the patient has a nickel allergy.Patient had pdc vivo devices removed on (b)(6) 2024.Both vivo implants were replaced with simplify ctdr.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels outlined in the risk documentation.A review of the risk assessment 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 because the implants were not returned following removal.There were no anomalies identified during the complaint investigation.The removal was likely caused by the infection, a cause for the infection is unknown.The submission is 1 of 2 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): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 18860775
• Report Number: 3007494564-2024-00019
• Device Sequence Number: 18202613
• Product Code: MJO
• UDI-Device Identifier: 00843193113733
• UDI-Public: 00843193113733
• 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: 2023
• 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): 03/07/2024

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: 2022-1790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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: 46 YR
• Patient Sex: Female