MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92126

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

Patient Problems Ossification (1428); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 02, 2019.

Event Description

Per the clinic, the patient experienced bone overgrowth between the top the implant and the bottom of the abutment.Subsequently, the abutment was removed under general anaesthetic (date not reported).

• Brand Name: BIA300 IMPLANT 3MM 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: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8953145
• MDR Text Key: 156334822
• Report Number: 6000034-2019-01616
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/02/2019,08/12/2019

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: 92126
• Device Catalogue Number: 92126
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2019
• Distributor Facility Aware Date: 08/12/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention