MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92127

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Infection (4544)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on dec 17, 2021.

Event Description

Per the clinic, the patient experienced an infection (treatment unknown) at the abutment site.The connect device was converted to an osia device on (b)(6) 2021 i.E., the abutment was removed and the osia was placed on the existing implant.Further information is being sought from the clinic.

Manufacturer Narrative

There was no reported infection.This report is submitted on dec 17, 2021.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 13022647
• MDR Text Key: 282379962
• Report Number: 6000034-2021-03760
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

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: 92127
• Device Catalogue Number: 92127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female