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

Model Number 09.820.045S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 320412441
• Report Number: 3007494564-2023-00039
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193112811
• UDI-Public: 00843193112811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 09.820.045S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female