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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that a patient had a pdl implant placed in 2002.The decision was made in (b)(6) 2022 to remove the implant and to fuse the patient with a fusion 4web.No reason or cause for removal of the pdl was given.Additionally, there was no indication of device malfunction.

Manufacturer Narrative

It was reported that a patient had a prodisc l implant placed in 2002, the pdl implant was removed on (b)(6) 2022 and the patient was fused using a fusion 4web device.No patient symptoms or hazardous situations were reported.Several unsuccessful attempts were made to gain more information about the complaint.A review of the dhr could not be completed as the part number and lot number were not reported.Complaint trending showed that the rate of complaints is at the lowest possible level of improbable.A review of the risk assessment found that the risk associated with the complaint are identified and mitigated to the lowest possible level.A device evaluation could not be completed as the implant was not returned for evaluation.It was confirmed that a prodisc l removal was completed.The investigation did not determine a cause for the removal, no device malfunction is indicated.This submission is 1 of 3 devices involved in this event.

• Brand Name: PRODISC L IMPLANT SUPERIOR PLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 15320956
• MDR Text Key: 298891469
• Report Number: 3007494564-2022-00041
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2022

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: 08/02/2022
• Initial Date FDA Received: 08/30/2022
• 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