MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93332

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the clinic, the patient developed an infection at the implant site.Additional information has been requested but has not been made available as of the date of this report.

Event Description

It was the reported the patient had been treated with oral antibiotics for a month, for the recurring infection.The patient underwent a revision surgery on (b)(6) 2021, in order to explant the internal fixture and abutment, and remove tissue around the abutment.Reimplantation is planned once the wound has healed.Patient identifier and product details have been added.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43522 ; SW 43522
• MDR Report Key: 12298942
• MDR Text Key: 265771388
• Report Number: 6000034-2021-02355
• 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: 08/19/2021,08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: 134652
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2021
• Distributor Facility Aware Date: 08/02/2021
• Date Report to Manufacturer: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention