MAUDE Adverse Event Report: CENTINEL SPINE PRODISC L INFERIOR PLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Several attempts were made unsuccessfully to collect more information on this case.All that is known is that the surgeon completed two prodisc l removals on a patient with pdl implants at two levels.The patient was involved in a motor vehicle accident and as a result of the trauma experienced pdl inlay expulsion at both levels.The dates of implantation and removal are unknown.An mdr is indicated for this complaint.A review of the dhrs could not be completed as the part numbers and lot numbers were not provided and could not be determined during the investigation.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation cannot be completed as the as the implants were not returned following the removal.It was confirmed that a removal took place due to inlay expulsion following patient trauma.No other anomalies associated with the complaint were found during the investigation.The submission is 6 of 6 devices involved in this event.

Event Description

It was indicated during a spine conference that a surgeon completed two prodisc l removals on a patient with pdl implants at two levels.The patient was involved in a motor vehicle accident and as a result of the trauma experienced pdl inlay expulsion at both levels.The dates of implantation and removal are unknown.

• Brand Name: PRODISC L INFERIOR PLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 18302740
• MDR Text Key: 330182784
• Report Number: 3007494564-2023-00077
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention