MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C US IMPLANT EXTRALARGE-DEEP 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.076S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Neuropathy (1983); Neck Pain (2433)
Date of Event	06/15/2026
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 pdc device at level c3-4 on (b)(6) 2023.Patient has a history of multiple spinal fusions in her cervical, thoracic, and lumbar spine as well as osteoporosis and left sacroiliitis.Patient had been experiencing neck pain, and numbness and tingling in arms and hands, and daily headaches.The surgeon completed a pdc removal on (b)(6) 2026 and fused the patient.A dhr review 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 harms.The implant was returned following the removal surgery and will be evaluated using an approved cervical implant evaluation protocol.Imaging was provided that showed the device was used in an off-label configuration with multiple fused levels below the pdc implant.There were no anomalies identified during the complaint investigation.The removal was likely caused by the patient specific condition of osteoporosis which resulted in the off-label use of the implant next to fused levels.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient (70 yo, female) was implanted with a pdc device at level c3-4 on (b)(6) 2023.Patient has a history of multiple spinal fusions in her cervical, thoracic, and lumbar spine as well as osteoporosis and left sacroiliitis.Patient had been experiencing neck pain, and numbness and tingling in arms and hands, and daily headaches.The surgeon completed a pdc removal on (b)(6) 2026 and fused the patient.

• Brand Name: PRODISC C US IMPLANT EXTRALARGE-DEEP 6MM
• 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: 25627117
• Report Number: 3007494564-2026-00061
• Device Sequence Number: 8983952
• Product Code: MJO
• UDI-Device Identifier: 00843193112910
• UDI-Public: (01)00843193112910(17)251231(10)2021-0999
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2026
• 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): 06/25/2026

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 Expiration Date: 12/31/2025
• Device Model Number: 09.820.076S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-0999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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: 70 YR
• Patient Sex: Female