MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92127

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 15, 2017, by cochlear ltd.On behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient underwent revision surgery on (b)(6) 2017, in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.No other event or complications that may have contributed to the decision to convert the patient were reported.

Manufacturer Narrative

Per the clinic, it was reported that prior to conversion, the patient had experienced recurrent infections at the implant site.Treatment with antibiotics were unsuccessful, resulting in the decision to convert.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT 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: bianca pries ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7031184
• MDR Text Key: 92019518
• Report Number: 6000034-2017-02116
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019521
• UDI-Public: (01)09321502019521(10)91640(17)160731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 12/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92127
• Device Catalogue Number: 92127
• Device Lot Number: 91640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention