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

Model Number	OP8330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the initial report, the surgeon stated that a patient experienced an implant fracture and needed a replacement for surgery intervention.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: EAR IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd., sw; ste# 120; atlanta GA 30349
• MDR Report Key: 12407603
• Report Number: 3009383407-2021-00002
• Device Sequence Number: 11810090
• Product Code: FZD
• UDI-Device Identifier: 00855421005284
• UDI-Public: 00855421005284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: OP8330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention