MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB

Model Number BIA300

Device Problem Loss of Osseointegration (2408)

Patient Problem Hearing Loss (1882)

Event Type  Injury  

Manufacturer Narrative

The date of initial implantation is not unknown.Device not returned to manufacturer.

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (date not reported).Revision surgery is planned; however, has yet to occur as of the date of this report, (b)(6) 2016.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2017, in order to place an internal magnet.The implanted fixture remains insitu.This report is submitted january 19, 2017.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5687693
• MDR Text Key: 46158339
• Report Number: 6000034-2016-01086
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

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: BIA300
• Device Catalogue Number: 92346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 05/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• 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