MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR OSIA OSI200 IMPLANT; COCHLEAR¿ OSIA¿ SYSTEM

Model Number OSI200

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on october 23, 2023.

Manufacturer Narrative

Per the patient's surgeon, the revision surgery to tighten fixation screw was performed on (b)(6) 2023 under general anaesthetic.The previous or initial mdr submitted on october 23, 2023 was filed inadvertently.No loss of osseointegration has occurred.This report is submitted on december 08, 2023.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: hakim muhaimin jamil ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17982864
• MDR Text Key: 326232949
• Report Number: 6000034-2023-03407
• Device Sequence Number: 1
• Product Code: PFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2023
• Device Model Number: OSI200
• Device Catalogue Number: 92129
• Device Lot Number: COH1434690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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
• Patient Sex: Female