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

Model Number	09.820.036S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Vertebral Fracture (4520)
Date of Event	03/16/2026
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 prodisc c device at c4-5 on (b)(6) 2025.Patient has a fracture of c5, left side worse than right, causing scoliosis.There is gross instability and migration of the implant seen upon flex-ex imaging.C5-7 is kyphotic and large anterior osteophytes at c6-7.Patient has ongoing pain.A removal was completed on (b)(6) 2026 and the patient was fused.A dhr review found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outlined defined 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 not returned following the removal surgery therefore no device evaluation could be completed.Imaging was provided that showed the implant migration.There were no anomalies identified during the complaint investigation.The implant removal was completed due to implant migration.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
A patient (51 yo, female) was implanted with a prodisc c device at c4-5 on (b)(6) 2025.Patient has a fracture of c5, left side worse than right, causing scoliosis.There is gross instability and migration of the implant seen upon flex-ex imaging.C5-7 is kyphotic and large anterior osteophytes at c6-7.Patient has ongoing pain.A removal was completed on (b)(6) 2026 and the patient was fused.

• Brand Name: PRODISC C US IMPLANT MEDIUM-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): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, che 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 24752752
• Report Number: 3007494564-2026-00031
• Device Sequence Number: 10214885
• Product Code: MJO
• UDI-Device Identifier: 00843193112798
• UDI-Public: (01)00843193112798(17)260831(10)2021-1797
• 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: 2025
• 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): 03/31/2026

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: 08/31/2026
• Device Model Number: 09.820.036S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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: 51 YR
• Patient Sex: Female