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

Catalog Number 90432

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is filed, june 6, 2016.The implanted device remains.

Event Description

It was reported that the patient may have developed an infection at the implant site.The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient experienced an infection of the mastoid bone and subsequently underwent surgery to remove infected bone (date not reported).This report is submitted february 20, 2017.

Manufacturer Narrative

Correction: the previous follow up mdr submitted on february 20, 2017, was filed inadvertently.The infection was not device related.This report is filed on february 24, 2017.(b)(4).

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw, CO 2109 ; AS 2109 ; 3037909010
• MDR Report Key: 5701922
• MDR Text Key: 46646868
• Report Number: 6000034-2016-01135
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 90432
• Device Lot Number: 005CMC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention