MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92132

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the device details and rationale for conversion; however, have not been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on december 23, 2019.

Event Description

Per the clinic, the patient underwent revision surgery on (b)(6) 2019, in order to remove the external abutment and have a magnet placed on the internal fixture, converting the patient to a transcutaneous baha implant system.

• Brand Name: BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
• 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 Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9508798
• MDR Text Key: 172372802
• Report Number: 6000034-2019-02854
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92132
• Device Catalogue Number: 92132
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• 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
• Patient Age: 18 YR