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

Model Number	PDNL5
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient (59 year old male) was implanted with two prodisc c nova devices at c4-5 and c5-6 on (b)(6) 2025.The patient was symptomatic having pain that prevented him from sleeping and it was found that the implant had migrated anteriorly.A one level removal of the implant at c5-6 was completed on (b)(6) 2025 and it was found that the implant was completely unfixed to the vertebrae and that the level was infected with p.Acne bacteria.The patient was fused with a cage and plate and treated with antibiotics administered in a picc line.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient (59 year old male) was implanted with two prodisc c nova devices at c4-5 and c5-6 on (b)(6) 2025.The patient was symptomatic having pain that prevented him from sleeping and it was found that the implant had migrated anteriorly.A one level removal of the implant at c5-6 was completed on (b)(6) 2025 and it was found that the implant was completely unfixed to the vertebrae and that the level was infected with p.Acne bacteria.The patient was fused with a cage and plate and treated with antibiotics administered in a picc line.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.The implant was returned following the removal surgery, and will be evaluated using exponents approved prodisc c evaluation protocol.The report will be issued under (b)(4).No pre-removal imaging was provided.There were no anomalies identified during the complaint investigation.The removal was due to implant migration which was caused my a patient infection at the index level.The submission is 1 of 2 devices involved in this event.

• Brand Name: PRODISC C NOVA 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 ; 4848878894
• MDR Report Key: 24036069
• Report Number: 3007494564-2026-00004
• Device Sequence Number: 21450787
• Product Code: MJO
• UDI-Device Identifier: 00843193113559
• UDI-Public: (01)00843193113559(17)290630(10)2024-0638
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: PDNL5
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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: 59 YR
• Patient Sex: Male