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

Model Number BI300

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is filed on may 04, 2016.Implanted device remains.

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.The patient was placed under general anesthesia and underwent revision surgery to remove excess skin (date not reported).

• 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: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 5629627
• MDR Text Key: 44329004
• Report Number: 6000034-2016-00872
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BI300
• Device Catalogue Number: 92128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• 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