MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92997

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Date 11/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced skin overgrowth on the abutment.Subsequently, the patient underwent revision surgery under general anesthesia to excise the excess skin and for removal of the abutment on (b)(6) 2016.

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM
• 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: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6192193
• MDR Text Key: 62906368
• Report Number: 6000034-2016-02515
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92997
• Device Catalogue Number: 92997
• Device Lot Number: 155998
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• 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: 16 YR