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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that the clinical account manager received a call from the distributor regarding a patient that came into the er with abdominal pain.A picture was sent of the lumbar spine which clearly shows a pdl implant expulsing from the anterior portion of the body.Come to find out later that evening, the patient's pain was not related to the implant, but rather a gallbladder and was taken in for surgery and the gallbladder removed.According to the surgeon the patient isn't having symptoms related to the expulsed implant, that was picked up on imaging from the er.The surgeon has decided not to move forward with a pdl removal as the implant is around 8-10 years old and not causing the patient any symptoms.

Manufacturer Narrative

It was reported that a patient was implanted approximately 8-10 years ago with a prodisc l implant.On (b)(6) 2023 the patient reported to the emergency room with abdominal pain.An x-ray found that the pdl implant was expulsed (migrated) from the anterior portion of the body.It was later determined that the pain was caused by the patient's gallbladder and a gallbladder removal surgery relieved all of the symptoms.According to the surgeon the patient is not having any symptoms related to the expulsed implant.The surgeon made the decision not to remove the implant.The complaint was found to be an mdr reportable complaint due to a device malfunction that could lead to serious patient harm.A review of the dhr could not be completed as the part number and lot number were not provided and could not be determined based on the information that was collected during the investigation.Complaint trending found the rate of complaints to be at a level where the benefits outweigh the risks.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated.Device evaluation could not be completed as the implant remains implanted within the patient.There were no anomalies associated with the complaint identified during the investigation, the cause for implant migration is unknown.This report is for 2 of 3 devices involved in this event.

• 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 (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16502219
• MDR Text Key: 310875961
• Report Number: 3007494564-2023-00012
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2023
• 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