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

Model Number	PDVM5
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Speech Disorder (4415); Swelling/ Edema (4577)
Date of Event	12/20/2022
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 on (b)(6) 2022 at levels c5-6.After implantation patient experienced a rash, pharyngeal edema, muscle tension, dysphonia, and dysphagia.It was stated that the patient has a nickel sensitivity confirmed by a blood test.Patient has not had the implant removed and symptoms persist.A review of the dhr 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 documents found that the hazards associated with this complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.A device evaluation could not be completed as the pdc vivo device remains implanted in the patient.No anomalies were identified during the investigation.The patient's symptoms are likely due to the nickel sensitivity.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient reported that they had a c5-6 artificial disc replacement with prodisc c vivo on (b)(6) 2022.Patient is experiencing rashes and welts on their body as well as pharyngeal edema, muscle tension, dysphonia, and dysphagia.Their symptoms developed within a few days of implantation of the pdc vivo device and have not improved since.A blood test did confirm that the patient had a nickel allergy.

• 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): 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: 18861310
• Report Number: 3007494564-2024-00021
• Device Sequence Number: 8283046
• Product Code: MJO
• UDI-Device Identifier: 00843193113672
• UDI-Public: 00843193113672
• 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: 2022
• 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: PDVM5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• 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: 49 YR
• Patient Sex: Female