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

Model Number BIA210

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The date of initial implantation is unknown per the date of this report.This report is filed on july 6, 2016.(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced a chronic infection with granulation tissue at the implant site.The issue could not be resolved, and the patient was subsequently placed under general anesthesia in order to remove the abutment on (b)(6) 2016.The implanted device remains.

• 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 (Section G): COCHLEAR AMERICAS; 13059 east parkview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5771257
• MDR Text Key: 48816454
• Report Number: 6000034-2016-01331
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIA210
• Device Catalogue Number: 32135
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/24/2016
• Date Manufacturer Received: 06/24/2016
• 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