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

Model Number 92126

Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 2, 2020.

Event Description

Per the clinic, the patient experienced a loss of osseointegration of the implant.It is unknown if the patient has been re-implanted with another device.

• 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: roberta loveday ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 9537259
• MDR Text Key: 173275214
• Report Number: 6000034-2020-00013
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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