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

Model Number	09.820.055S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a prodisc c device at level c5-c6 on (b)(6) 2021.The implant was removed on (b)(6) 2023.The patient presented with radiculopathy and kyphosis at the c5-c6 index level where the device was implanted.X-ray images were provided.The reason for the removal was the implant had migrated posteriorly and the surgeon noted during the removal surgery that the endplates of the prodisc c device were not integrated with the bone from the vertebral bodies.
Additional Manufacturer Narrative
A review of the device history record was conducted and found no ncmr's, deviations, or anomalies.Complaint trending showed that the rate of complaints remains within acceptable limits.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.A device evaluation could not be completed as there was no indication the hospital released the implant.The complaint investigation did not identify a cause for the implant migration which led to the removal surgery.Based on the surgeon's comments, there was no malfunction of the device and the patient's symptoms of radiculopathy and kyphosis were likely caused by the implant's posterior migration following the initial implantation surgery.There was no indication from the post-operative x-rays after the initial implantation surgery that the implant placement was incorrect or there was any anomalies with the patient's bony anatomy which may have contributed to the migration.This submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C US IMPLANT LARGE-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): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer Contact: matthew crilley ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878849
• MDR Report Key: 17259951
• Report Number: 3007494564-2023-00033
• Device Sequence Number: 5960311
• Product Code: MJO
• UDI-Device Identifier: 00843193112842
• UDI-Public: 00843193112842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/28/2023

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: 03/31/2025
• Device Model Number: 09.820.055S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 38 YR
• Patient Sex: Male