MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93331

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 15, 2016.(b)(4).

Event Description

Per the clinic, the patient experienced pain at abutment site, subsequently the device was explanted on (b)(6) 2016.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.

Manufacturer Narrative

Correction: the initial mdr submitted on december 15, 2016 was filed inadvertently, no explant occurred.The patient experienced a loss of osseointegration, resulting in fixture loss.(b)(4).

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• 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: 6176033
• MDR Text Key: 62426476
• Report Number: 6000034-2016-02566
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH784997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR