MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

This report is submitted on xxxx 2018, by (b)(4).

Event Description

Per the clinic, the patient developed a seroma over the implant site.The site was drained on (b)(6) 2015, and the wound was pressure wrapped.On (b)(6) 2016, the patient underwent revision surgery on (b)(6) 2016, in order to remove the internal magnet and place an abutment on the fixture.On (b)(6) 2016, the patient experienced drainage and skin overgrowth at the implant site, which was subsequently cauterized.On (b)(6) 2017, the overgrowth and granulation re-occurred, resulting in further treatment involving cauterization of the site, use of silver nitrate and performing a biopsy punch.The implanted fixture remains inisitu.

• Brand Name: BI300 IMPLANT 4 MM
• 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 (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7521067
• MDR Text Key: 108481058
• Report Number: 6000034-2018-01132
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)162396(17)190831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 04/19/2018

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 Expiration Date: 08/31/2019
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: 162396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR