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

Model Number	09.820.046S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/11/2026
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 on (b)(6) 2019.The patient developed myelopathy and it was found that the implant had migrated and patient was experiencing osteolysis.The implant was removed on (b)(6) 2026.The removal surgeon does not believe the myelopathy is caused by the device.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 not returned following the removal surgery therefore no device evaluation can be completed.Additionally, no imaging was provided for the complaint.There were no anomalies identified during the complaint investigation.The removal was due to implant migration.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient (42yo, female) was implanted with a pdc device on (b)(6) 2019.The patient developed myelopathy and it was found that the implant had migrated and patient was experiencing osteolysis.The implant was removed on (b)(6) 2026.The removal surgeon does not believe the myelopathy is caused by the device.

• Brand Name: PRODISC C US IMPLANT LARGE 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: 24708858
• Report Number: 3007494564-2026-00029
• Device Sequence Number: 21449542
• Product Code: MJO
• UDI-Device Identifier: 10705034763798
• UDI-Public: (01)10705034763798(17)220131(10)H580269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/26/2026

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: 01/31/2022
• Device Model Number: 09.820.046S
• Device Catalogue Number: N/A
• Device Lot Number: H580269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2018
• 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: 42 YR
• Patient Sex: Female