MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92130

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 7, 2017, (b)(4).

Event Description

Per the clinic, the patient experienced soft tissue complications at the implant site.Subsequently, the patient was treated with oral and topical antibiotics (date and duration not reported); however, the patient continued to experienced skin overgrowth issues.Revision surgery is scheduled; however, yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2017 in order to excise infected tissue at the abutment site and have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.

• Brand Name: BA300 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: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7005423
• MDR Text Key: 91182612
• Report Number: 6000034-2017-01995
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ASKU
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92130
• Device Catalogue Number: 92130
• Device Lot Number: N/I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention