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 Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 28, 2020.

Event Description

Per the clinic, it was reported that the patient developed significant skin issues at the implant site and a loss of benefit.The patient was subsequently treated with antibiotics for the reported skin issues (type not reported).There are plans to reimplant the patient with another cochlear device to achieve a greater audiological gain.

• 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 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; po box 82; molnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10330668
• MDR Text Key: 200600543
• Report Number: 6000034-2020-01917
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019521
• UDI-Public: (01)09321502019521(10)87451(17)160331
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 92127
• Device Catalogue Number: 92127
• Device Lot Number: 87451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• 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