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

Model Number 92130

Device Problem Osseointegration Problem (3003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is filed (b)(6) 2016, by (b)(4).Device disposition unknown.

Event Description

Per the clinic, the patient experienced a possible loss of osseointegration.Revision surgery is scheduled, however; yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, it was confirmed that there was no loss of osseointegration; however, skin had grown over the implant.Subsequently, the patient was placed under general anaesthesia in order to place a longer abutment.This report is submitted january 31, 2017.

• 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 AMERICAS; 13059 east peakview avenue; centennial 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6127080
• MDR Text Key: 60843872
• Report Number: 6000034-2016-02319
• Device Sequence Number: 1
• Product Code: LXB
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• 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: COH200160
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/10/2016
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention