MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM

Device Problem Loss of Osseointegration (2408)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the recipient experienced a loss of osseointegration(date not reported). As per the clinic, there was no medicine prescribed for the skin where the baha system fell out as this was already well healed. The recipient is now wearing his baha 5 power on a softband.

• Brand Name: NI
• 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; 43533 ; SW 43533
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9243417
• MDR Text Key: 163893434
• Report Number: 6000034-2019-02129
• 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: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/04/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/27/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 10/04/2019
• Event Location: Home
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/27/2019 Patient Sequence Number: 1