MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92131

Device Problem Missing Value Reason (3192)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

Additional information regarding the product details were requested; however, not made available as of the date of this report.This report is submitted on march 7, 2017.(b)(4).

Event Description

Per the clinic, the patient sustained a trauma to the implant site, resulting in displacement of the abutment.Subsequently, the patient developed adverse skin reactions and granulomas that required revision.On (b)(6) 2017, the device was explanted in order to allow for the site to heal.

Manufacturer Narrative

Correction: no explantation has occurred.The abutment was removed and subsequently the patient was treated with a steroid injection.The implanted device remains.This report is submitted on april 18, 2017.

• Brand Name: BA300 ABUTMENT 9MM
• 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: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6382574
• MDR Text Key: 69202520
• Report Number: 6000034-2017-00497
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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: 92131
• Device Catalogue Number: 92131
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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