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

Catalog Number 92128

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

This report is filed february 9, 2016. Device not received by manufacturer.

Event Description

Per the clinic, the patient experienced a loss of osseointegration on (b)(6) 2015. It is unknown whether the loss of osseointegration resulted in a fixture loss.

• 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: 5418208
• MDR Text Key: 37717476
• Report Number: 6000034-2016-00362
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: CO
• PMA/PMN Number: K955713
• 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: 01/28/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/08/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device Catalogue Number: 92128
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/28/2016
• 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 TREATMENT DATA

Date Received: 02/08/2016 Patient Sequence Number: 1