MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 14MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93338

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient underwent revision surgery (specific date not reported) in order to convert the patient to a transcutaneous osia baha implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced multiple skin infections, that were unresponsive to multiple courses of antibiotics (topical and oral), steroids (topical) and skin revision.

Manufacturer Narrative

Per the clinic, the patient experienced multiple skin infections, that were unresponsive to multiple courses of antibiotics (topical and oral), steroids (topical) and skin revision.This report is submitted on october 19, 2020.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 14MM
• 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
• MDR Report Key: 10578105
• MDR Text Key: 208302900
• Report Number: 6000034-2020-02632
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/19/2020,09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2022
• Device Model Number: 93338
• Device Catalogue Number: 93338
• Device Lot Number: COH1096805
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2020
• Distributor Facility Aware Date: 09/03/2020
• Date Report to Manufacturer: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention