MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT EXTRALARGE-DEEP 7MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.077S
Medical Device Problem Codes	Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient (58yo, female) was implanted with a pdc device at c6-7 on (b)(6) 2025.Patient had previously had an acdf at level c5-6, completed in 2005.Patient had initial symptom relief but then was experiencing worsening pain.It was found that the patient had a c7 fragility fracture, and pdc device subsidence with kyphosis and anterior migration.The pdc device was removed on (b)(6) 2026 and the patient an acdf peek interbody with plate and screws.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 for device evaluation and will be evaluated using exponent's approved prodisc c evaluation protocol.The report will be issued under (b)(4).Additionally, imaging was provided that showed the subsided implant.There were no anomalies identified during the complaint investigation.The removal was completed due to implant subsidence, kyphosis, and anterior migration.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
A patient (58yo, female) was implanted with a pdc device at c6-7 on (b)(6) 2025.Patient had previously had an acdf at level c5-6, completed in 2005.Patient had initial symptom relief but then was experiencing worsening pain.It was found that the patient had a c7 fragility fracture, and pdc device subsidence with kyphosis and anterior migration.The pdc device was removed on (b)(6) 2026 and the patient an acdf peek interbody with plate and screws.

• Brand Name: PRODISC C US IMPLANT EXTRALARGE-DEEP 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: 24432491
• Report Number: 3007494564-2026-00010
• Device Sequence Number: 10227320
• Product Code: MJO
• UDI-Device Identifier: 00843193112927
• UDI-Public: (01)00843193112927(17)30APR2026(10)2022-0166
• 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): 02/24/2026

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: 04/30/2026
• Device Model Number: 09.820.077S
• Device Catalogue Number: N/A
• Device Lot Number: 2022-0166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2022
• 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: 58 YR
• Patient Sex: Female