MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Irritation (1941)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 04, 2018.(b)(4).

Event Description

It was reported that the patient experienced headaches/migraines and irritation at the implant site.Subsequently, the irritation was treated with a steroid cream on (b)(6) 2018.There are plans to remove the magnet and place an abutment; however is yet to occur as of the date of this report.

Manufacturer Narrative

It was reported that the patient underwent revision surgery on (b)(6) 2018, 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: BI300 IMPLANT 4 MM
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7661783
• MDR Text Key: 113156323
• Report Number: 6000034-2018-01418
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH839908(17)210209
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2021
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH839908
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• 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 Age: 33 YR