MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB 93550; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problem Extrusion (2934)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 7, 2018, (b)(4).

Event Description

Per the clinic, the patient experienced a breakdown of the skinflap, resulting a partial exposure of the internal magnet.Revision surgery is planned; however, it is unknown if this has yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient underwent skin revision surgery on (b)(6) 2018.The implanted device remains.

Manufacturer Narrative

Correction: there was no reported problem with the internal magnet.

• Brand Name: 93550
• Type of Device: COCHLEAR BAHA ATTRACT 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: 7319016
• MDR Text Key: 101689299
• Report Number: 6000034-2018-00464
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 93885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 04/16/2018
• Supplement Dates FDA Received: 04/11/2018; 05/09/2018
• 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