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

Model Number	PDVMD5
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with two prodisc c vivo implants at c5-6 and c6-7 on (b)(6) 2024.Patient became symptomatic and received a facet injection in (b)(6) 2024 to no significant improvement.It was found that the patient had a previously unknown nickel allergy.A second surgeon removed the implants on (b)(6) 2025 and replaced them with a nickel free disc replacement device.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc c vivo implants at c5-6 and c6-7 on (b)(6) 2024.Patient became symptomatic and received a facet injection in (b)(6) 2024 to no significant improvement.It was found that the patient had a previously unknown nickel allergy.A second surgeon removed the implants on (b)(6) 2025 and replaced them with a nickel free disc replacement device.A dhr review found no anomalies associated with the complaint.Complaint trending found the rate of complaints is at the lowest possible level of improbable.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.However, the calculated p2 value is above the limit outlined in the risk documentation and it will be updated.The implants were returned following the removal surgery and will be evaluated by exponent under their approved prodisc c device evaluation protocol.The report will be issued under (b)(4) and (b)(4).Imaging was provided but no device malfunctions were visible.There were no anomalies identified during the complaint investigation.The implant removals were completed due to a patient nickel allergy.The submission is 2 of 2 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT MEDIUM-DEEP 5M
• 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: 23016692
• Report Number: 3007494564-2025-00084
• Device Sequence Number: 9512150
• Product Code: MJO
• UDI-Device Identifier: 00843193113702
• UDI-Public: (01)00843193113702(17)281130(10)2023-1463
• 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
• 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): 09/09/2025

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: PDVMD5
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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: 40 YR
• Patient Sex: Male