MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; EAR IMPLANT

Model Number OP8330

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

According to the initial report, a patient is undergoing a surgery revision due to an ear implant fracture.The date of the surgery is unknown.Requests for additional information were made to no avail.As the lot number of the product is unknown, manufacturing records could not be reviewed.The investigation is currently ongoing.Any additional details will be provided in a follow-up report.

Event Description

According to the initial report, the surgeon stated that a patient experienced an implant fracture and needed a replacement for surgical intervention.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Type of Device: EAR IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd sw; suite 120; atlanta GA 30349
• Manufacturer Contact: darren troutman ; 4043440283
• MDR Report Key: 12408172
• MDR Text Key: 269386342
• Report Number: 3009383407-2021-00003
• Device Sequence Number: 1
• Product Code: FZD
• UDI-Device Identifier: 00855421005284
• UDI-Public: 00855421005284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K23908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP8330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• 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): Hospitalization; Required Intervention