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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that a prodisc l removal took place on (b)(6) 2023.

Manufacturer Narrative

It was reported that a prodisc l removal was completed (b)(6) 2023.A dhr removal could not be completed as the device lot number and part number were not provided and could not be determined during the investigation.Complaint trending showed the rate of complaints at the lowest possible level of improbable.The risk assessment found that the harm associated with the complaint is identified and mitigated to a level where the benefits outweigh the risks.A device evaluation could not be completed as the pdl implant was not returned for evaluation.No indication of the cause for the pdl removal, the complaint investigation outcome is unknown.This report is for 1 of 3 devices in this event.

Event Description

Update to add di number to report.

Manufacturer Narrative

Addition of di number.

• Brand Name: PRODISC L UNKNOWN SUPERIOR 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 ; 4848878894
• MDR Report Key: 16724438
• MDR Text Key: 313129308
• Report Number: 3007494564-2023-00019
• 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,Followup
• Report Date: 04/27/2023

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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/28/2023
• 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