MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Biocompatibility (2886)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 2, 2020.

Event Description

Per the clinic, it was reported that the patient experienced recurrent chronic infection at the implant site and was subsequently treated with multiple rounds of medication (type, date and duration not reported).It was reported that treatment to date has been unsuccessful.The patient continues to be managed by their healthcare provider.

Manufacturer Narrative

It was reported that the patient underwent revision surgery on (b)(6) 2018 to replace abutment.This report is submitted on 29 april 2021.

• Brand Name: BI300 IMPLANT 4MM
• 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: 10222397
• MDR Text Key: 197293202
• Report Number: 6000034-2020-01848
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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 Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention