MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C SK, MEDIUM, 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSM5
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc c sk device at c5-6 on (b)(6) 2025.At the 2 week follow up, the imaging showed that the implant may have slightly subsided and kyphosed.The patient is experiencing no symptoms and is doing well.There is no indication at present that any intervention will be performed.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is at the lowest possible probability of occurrence level of improbable.The risk assessment found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The sk device remains implanted in the patient and was not returned, therefore no evaluation could be completed.Imaging was provided that shows the subsided implant.There were no anomalies identified during the complaint investigation.A reason for the implant subsidence is unknown.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c sk device at c5-6 on (b)(6) 2025.At the 2 week follow up, the imaging showed that the implant may have slightly subsided and kyphosed.The patient is experiencing no symptoms and is doing well.There is no indication at present that any intervention will be performed.

• Brand Name: PRODISC C SK, MEDIUM, 5MM
• 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: 23084969
• Report Number: 3007494564-2025-00086
• Device Sequence Number: 10508787
• Product Code: MJO
• UDI-Device Identifier: 00843193113856
• UDI-Public: (01)00843193113856(17)271231(10)2022-1243
• 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: 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): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDSM5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female