MAUDE Adverse Event Report: CENTINEL SPINE PRODISC C US IMPLANT MEDIUM-DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.035S
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was implanted with a prodisc c device at c5/6 on (b)(6) 2022.Patient reported increased neck and arm pain after the procedure.It was found that the implant had changed position and was causing kyphosis and fish mouthing of the implant.Pdc implant removed on (b)(6) 2023 and fused the patient with a corelink 3d printed titanium cage.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels defined in the risk assessment.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation could not be completed as the implant was not returned from the hospital following the removal.There were no anomalies found during the complaint investigation.The implant migrated following surgery which led to implant kyphosis and fish mouthing.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
It was reported that a patient received a prodisc c implant on (b)(6) 2022.The patient experienced increased neck and arm pain and an x-ray found that there was a change in implant position resulting in kyphosis and fish mouthing of the implant.A prodisc c removal was completed on (b)(6) 2023.Patient was revised by a corelink 3d printed titanium cage.

• Brand Name: PRODISC C US IMPLANT MEDIUM-DEEP 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16859741
• Report Number: 3007494564-2023-00025
• Device Sequence Number: 14910463
• Product Code: MJO
• UDI-Device Identifier: 00843193112781
• UDI-Public: 00843193112781
• 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: 2022
• Device Explanted Year: 2023
• 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): 05/02/2023

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: 06/30/2025
• Device Model Number: 09.820.035S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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: 37 YR
• Patient Sex: Female