MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM

Model Number ASKU

Device Problems Expulsion (2933); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Breakdown (2681); Insufficient Information (4580)

Event Type  Injury  

Event Description

Per the clinic, the attract magnet was explanted on (b)(6) 2017 due to unknown reason.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced pain at the implant site and subsequently, was treated with oral and topical antibiotics for 10 days on (b)(6) 2016.The patient reported pain again on (b)(6) 2017 and was treated with 2 types of oral antibiotics for 14 days.It was reported that the patient experienced extrusion of the implant magnet.Subsequently, the patient underwent a revision surgery on (b)(6) 2017 under general anesthesia in order to convert the patient to a percutaneous baha implant system.During the procedure, the internal magnet was removed, and an abutment was placed on the internal fixture.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 15984824
• MDR Text Key: 305490585
• Report Number: 6000034-2022-03767
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2023,01/06/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2023
• Distributor Facility Aware Date: 01/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female