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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a prodisc c removal was completed on (b)(6) 2023, no other information was provided despite multiple attempts to collect information on the removal.A dhr review could not be completed as the part number and lot number were not provided and could not be determined during the investigation.Complaint trending showed the rate of complaints is within the levels defined in the risk documentation.A review of 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 pdc implant was not released from the hospital and could not be returned for evaluation.No indication for the cause of the pdc removal was determined, the complaint investigation outcome is unknown.The submission is 1 of 1 devices involved in this event.

Event Description

A pdc removal was completed on (b)(6) 2023.

• Brand Name: PRODISC C US IMPLANT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 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: 17012427
• MDR Text Key: 316105472
• Report Number: 3007494564-2023-00030
• Device Sequence Number: 1
• Product Code: MJO
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2023

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: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/26/2023
• 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