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

Model Number	09.820.056S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	04/16/2025
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 two prodisc c implants on (b)(6) 2020.Patient began to complaint of arm pain and it was found that the one implant had shifted posterior.The implant was removed on (b)(6) 2025 and the surgeon implanted a fibular strut with four hole plate.A dhr review 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 documents found that the hazards associated with the complaint are identified and mitigated to a level where a clinical benefit outweighs the harm.Following removal of the devices, they were not returned from the hospital, therefore no device evaluation could be completed.Imaging provided confirmed the migration of the implant.There were no anomalies identified during the complaint investigation.The implant removal was completed due to implant migration which was causing arm pain.The submission is 2 of 2 devices involved in this event.
Event or Problem Description
A patient was implanted with two prodisc c implants on (b)(6) 2020.Patient began to complaint of arm pain and it was found that the one implant had shifted posterior.The implant was removed on (b)(6) 2025 and the surgeon implanted a fibular strut with four hole plate.

• Brand Name: PRODISC C US IMPLANT LARGE-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): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 21984885
• Report Number: 3007494564-2025-00045
• Device Sequence Number: 4488189
• Product Code: MJO
• UDI-Device Identifier: 10705034763828
• UDI-Public: (01)10705034763828(17)220630(10)H686346
• 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: 2020
• 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): 05/07/2025

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: 06/30/2022
• Device Model Number: 09.820.056S
• Device Catalogue Number: N/A
• Device Lot Number: H686346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2018
• 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: 53 YR
• Patient Sex: Male