MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93330

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 1, 2020.

Event Description

Per the clinic, the patient experienced a loss of the implant osseointegration (date unknown).There was evidence of an infection.Information is being sought from the clinic of the infection treatment.

Manufacturer Narrative

There was no loss of osseointegration as previously reported.The patient underwent skin revision surgery to replace the abutment.The implanted device remains.This report is submitted 8 july 2020.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 8MM
• 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: 10016438
• MDR Text Key: 189586454
• Report Number: 6000034-2020-01154
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/01/2020,06/12/2020

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 Model Number: 93330
• Device Catalogue Number: 93330
• Device Lot Number: COH1237893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2020
• Date Report to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention