MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93331

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 13, 2021.

Event Description

Per the clinic, the patient experienced recurring infection at the abutment site.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

It was reported the patient was treated with oral antibiotics for the infection (previously reported).Product details updated.This report is submitted on november 4, 2021.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 43533 ; SW 43533
• MDR Report Key: 12458762
• MDR Text Key: 270993063
• Report Number: 6000034-2021-02964
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: 131828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention