MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C US IMPLANT LARGE 7MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.047S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2024
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 implant at c5-6 on (b)(6) 2023.It was later found that the implant had collapsed on the left side and was causing recurrent left c5-6 foraminal stenosis.The implant was removed (b)(6) 2024 and the patient was fused.A review of the dhr found no anomalies associated with the complaint.Complaint trending found 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.A device evaluation could not be completed as the implant was not returned following the removal surgery.Imaging was not provided that showed the collapsed implant.There were no anomalies associated with the complaint identified during the investigation, the removal was completed due to implant collapse / subsidence.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c implant at c5-6 on (b)(6) 2023.It was later found that the implant had collapsed on the left side and was causing recurrent left c5-6 foraminal stenosis.The implant was removed on (b)(6) 2024 and the patient was fused.

• Brand Name: PRODISC C US IMPLANT LARGE 7MM
• 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: 21152398
• Report Number: 3007494564-2025-00006
• Device Sequence Number: 9189920
• Product Code: MJO
• UDI-Device Identifier: 00843193112835
• UDI-Public: (01)00843193112835(17)260531(10)2021-1395
• 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: 2023
• Device Explanted Year: 2024
• 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): 01/14/2025

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 Expiration Date: 05/31/2026
• Device Model Number: 09.820.047S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2022
• 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: 35 YR
• Patient Sex: Male