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

Catalog Number 928646

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 04/08/2014

Event Type  Injury  

Event Description

Per the clinic, the clinician attached the incorrect programming pod to the baha processor.The batteries came out of the device.The device has been replaced and has been returned to the manufacturer for analysis.No reports of patient injury are associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This report is filed may 13, 2014.

• 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 22; AS 435 22
• Manufacturer Contact: rebekka jeger ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 1294286300
• MDR Report Key: 3794840
• MDR Text Key: 4475705
• Report Number: 6000034-2014-00684
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 928646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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