MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C TOTAL DISC REPLACEMENT; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.035S
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient was diagnosed for revision/removal of the prodisc c on (b)(6) 2020.Removal of the prodisc c device occured on (b)(6) 2020 due to continued pain.The patient was experiencing pain while looking up.The surgeon indicated this may be due to the implant being too tall for this patient despite the patient receiving a 5mm height implant.5mm is the shortest implant offering for prodisc c.Information provided by the reporter as well as the manufacturer investigation did not find any issues with the device itself.The risk assessment for this device identifies the risks associated with an incorrect implant size.There is no trend in complaints for this type of issue.The device was not made available for retrieval and analysis by the facility where the removal case was performed.
Event or Problem Description
A patient required surgical intervention to remove a prodisc c implant due to continued pain.The patient was experiencing pain, specifically when looking up.This patient was implanted with the device on (b)(6) 2019.The surgeon indicated that the implanted prodisc c device was too tall despite being a 5mm (shortest) height implant.

• Brand Name: PRODISC C TOTAL DISC REPLACEMENT
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester, pa
• MDR Report Key: 10212572
• Report Number: 3007494564-2020-00025
• Device Sequence Number: 2613764
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: 03/31/2022
• Device Model Number: 09.820.035S
• Device Catalogue Number: N/A
• Device Lot Number: H618369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR