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

Model Number 92127

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 3, 2020.

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.The patient was placed under a general anaesthetic on (b)(6) 2020, in order to remove the excess skin and replace the abutment.The implanted device remains.

• 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 Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10486269
• MDR Text Key: 205459330
• Report Number: 6000034-2020-02299
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019521
• UDI-Public: (01)09321502019521(10)123370(17)170531
• 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
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: 92127
• Device Catalogue Number: 92127
• Device Lot Number: 123370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• 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
• Patient Age: 12 YR