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

Catalog Number 92133

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report filed march 2016.Device remains implanted.

Event Description

Per the clinic, the patient experienced pain, inflammation and skin overgrowth at the implanted site.Subsequently the patient was administered with iv steriods in four sessions (date and duration not reported).The implanted device remains.

Manufacturer Narrative

Per the clinic, additionally, the patient experienced an infection at the implant site.This report is filed april 8, 2016.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 Contact: bianca hanlon ; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5473180
• MDR Text Key: 39424927
• Report Number: 6000034-2016-00363
• 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,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 92133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• 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