MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 9, 2019.

Event Description

Per the clinic, it was reported that the patient experienced skin overgrowth at the implant site.Topical ointment was applied to the site; however, the issue did not resolve.Subsequently, the patient underwent revision surgery on (b)(6) 2019, in order to excise excess skin and place a longer abutment.

• Brand Name: BI300 IMPLANT 3MM
• 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: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9170031
• MDR Text Key: 161662716
• Report Number: 6000034-2019-02077
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)162074(17)190831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NIK100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: 162074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• 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: 10 YR