MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Unspecified Infection (1930)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

As per the clinic, the device was explanted under a general anaesthetic on (b)(6) 2019 because of persistent headaches.A new device was not re-implanted.

Manufacturer Narrative

The patient experienced an infection at the abutment site that was treated with a topical medication (type not specified).This report is submitted on september 3, 2020.

Event Description

The patient experienced an infection at the abutment site that was treated with a topical medication (type not specified).

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• 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
• MDR Report Key: 8606398
• MDR Text Key: 144921037
• Report Number: 6000034-2019-00768
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: 09321502019545
• Combination Product (y/n): N
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2020,08/12/2020

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: 04/12/2017
• Device Model Number: 92129
• Device Catalogue Number: COH584365
• Device Lot Number: 122201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Date Report to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR