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

Model Number BIM400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Manufacturer Narrative

The initial date of implantation was not reported.This report is filed (b)(6), 2016.Implanted device remains.

Event Description

Per the clinic, the patient developed necrosis of the skin-flap at the magnet site, resulting in the decision to temporarily discontinue use of the device.The device remains implanted.

• 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
• MDR Report Key: 5485105
• MDR Text Key: 39839072
• Report Number: 6000034-2016-00603
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIM400
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• 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