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

Model Number	09.820.045S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial communications regarding this pdc removal provided minimal detail.Follow up with the distributor rep who covers this facility found that limited information was available from this case.The facility asked the rep to order removal instruments, but did not provide any further information.The only information provided regarding the complaint was the patient was experiencing pain.These unknown conditions led to a determination that an mdr submission is required.Dhr review could only be completed for the superior endplate component as other component part and lot numbers were not legible and the implantation case could not be traced.The dhr review did not find any problems during manufacturing that may have caused or contributed to the event.The risk assessment determined the associated risks were acceptable based on the latest revision to the device risk assessment.The device was retrieved and undergoing stage i analysis at exponent as of this complaint.There has been no initial indication of a device problem.This submission is for 1 of 1 devices involved in this event.
Event or Problem Description
A patient received an unknown prodisc c implant on an unknown date.Due to unknown reasons, the patient was diagnosed for prodisc c removal.Little information about this case has been provided.The patient was experiencing pain, but there was no clear reason why the device was removed.Data forms from the facility indicate device removal due to failed cervical fusion; however, it is not clear if there was an adjacent fusion as this device is not a cervical fusion device.There was no indication whether the device was causing or contributing to the patient's pain.There was no indication of a device malfunction.The prodisc c device was removed on (b)(6) 2020.The replacement device or procedure is unknown.

• Brand Name: PRODISC C US IMPLANT LARGE 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12183554
• Report Number: 3007494564-2021-00061
• Device Sequence Number: 14159448
• Product Code: MJO
• UDI-Device Identifier: 00843193112811
• UDI-Public: 00843193112811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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 Model Number: 09.820.045S
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 07/16/2021
• 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