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

Model Number	09.820.045S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient was implanted with a prodisc c device at level c6-c7 on (b)(6) 2021.The implant was removed on (b)(6) 2023 with no reason for the removal being provided.Complaint trending showed that the rate of complaints remains within acceptable limits as defined in the risk documentation.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 the patient requested to keep all explanted components.No indication for the cause of the pdc removal was determined.Therefore, the complaint investigation outcome 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 device at level c6-c7 on (b)(6) 2021.The implant was removed on (b)(6) 2023.No information or imaging was provided to detail the patient's condition or reason for the removal.The implant was replaced with a fusion device.

• Brand Name: PRODISC C US IMPLANT LARGE 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 19380 ; 4848878849
• MDR Report Key: 17461045
• Report Number: 3007494564-2023-00039
• Device Sequence Number: 7153171
• Product Code: MJO
• UDI-Device Identifier: 00843193112811
• UDI-Public: 00843193112811
• 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: 2021
• Device Explanted Year: 2023
• 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): 08/04/2023

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: 09.820.045S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female