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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that a prodisc c device was removed and the patient was converted to fusion, no further information was made available by the reporter.A dhr review could not be completed as the part number and lot number were not provided.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 an acceptable level.A device evaluation could not be completed as the pdc implant was not returned for evaluation.No indication of the cause for the pdc removal, the complaint investigation outcome is unknown.This submission is 1 of 1 devices involved in this event.

Event Description

A prodisc c removal was completed on (b)(6) 2022.The patient was converted to a fusion device.

• Brand Name: PRODISC C US IMPLANT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 15429024
• MDR Text Key: 299972347
• Report Number: 3007494564-2022-00045
• 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: 09/13/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/15/2022
• 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