MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90432

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the audiologist, it was reported that the patient experienced a skin overgrowth at the abutment site and was administered a steroid injection (date not reported).Subsequently, the patient underwent revision surgery (date not reported), in order to convert the patient to a percutaneous baha implant system.During the procedure, the abutment was removed and a magnet was placed on the internal fixture.

• Brand Name: FLANGE FIXTURE ST 4MM
• 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: tamara martin ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8224744
• MDR Text Key: 132333383
• Report Number: 6000034-2018-02474
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90432
• Device Catalogue Number: 90432
• Device Lot Number: 607337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• 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