MAUDE Adverse Event Report: GYRUS ACMI, INC MICRON II 2.5MM OCTR ALL TITANIUM PORP; MICRON II ALL TITANIUM OFFCENTERED PORP

Model Number 70142030

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned as it is reportedly not available.In addition, insufficient information regarding the details of the reported event were provided.Multiple follow-ups were made to obtain additional information, but with no results.No dhr records could be reviewed as there was no lot number reported.In addition, there was no purchase record available.The cause of the reported event cannot be confirmed.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that the partial ossicular replacement prosthesis device was installed in the patient's ear in 2014 and broke inside the patient two years later.In (b)(6)2016, the patient had consulted a specialist who informed the patient the device had reportedly broken in two pieces and an intervention procedure at another hospital was performed to remove and replace the broken device with a non-olympus device.It was also reported the patient was kept for an extended period.A follow-up was conducted on the patient in (b)(6) 2016, and the patient is reportedly doing fine.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Further investigation was conducted by olympus.Based on the collected information, olympus was unable to determine if the referenced device is an olympus product associated with the reported event and that it is likely the user facility mixed the product with a non-olympus implant device.The complaint database was reviewed for all the parts in 70142030 family in the last three years and this is the only complaint related to any of these products.In addition, the maude database was also searched for the last 10 years for all parts in the micron ii monolithic off-centered porp family, and there were no complaints for these products.No conclusion could be reached as there is no historical data of this occurring in the past and the referenced device was not returned for evaluation.

• Brand Name: MICRON II 2.5MM OCTR ALL TITANIUM PORP
• Type of Device: MICRON II ALL TITANIUM OFFCENTERED PORP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8229995
• MDR Text Key: 132622807
• Report Number: 2951238-2019-00341
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• PMA/PMN Number: K002737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70142030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention