MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM

Model Number UNKNOWN

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Patient and device details unavailable at the time of this report, this report is submitted on may 17, 2017.(b)(4).

Event Description

Per the clinic, the patient experienced pain, swelling and a loss of osseointegration.Subsequently the implant magnet was explanted (date not reported).

Manufacturer Narrative

Correction: there was no loss of osseointegration as previously reported.It was reported that the implant magnet was loose and subsequently the magnet was explanted (date not reported).(b)(4).

• Brand Name: UNKNOWN
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6571474
• MDR Text Key: 75306678
• Report Number: 6000034-2017-00913
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention