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

Model Number 93332

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 7 february 2020.

Event Description

Per the clinic, it was reported that during surgery the clinician experienced complications due to a faulty drill, as a result the surgery could not be completed and will be attempted again at a later date.There was no allegation of serious injury associated with the event.The drill has not been returned to the manufacturer as of the date of this report.

Event Description

It was reported that the patient experienced a loss of osseointegration following initial surgery.

Manufacturer Narrative

This report is submitted on 16 march 2020.

Event Description

It was reported that the patient was treated with topical antibiotics.

Manufacturer Narrative

This report is submitted on (b)(6) 2020.

Manufacturer Narrative

This report is submitted on (b)(6) 2020.

Event Description

It was reported that the patient had an abscess following initial surgery.

• 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, 435 2 2; SW 435 22
• MDR Report Key: 9679540
• MDR Text Key: 178124504
• Report Number: 6000034-2020-00453
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2020,06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2020
• Distributor Facility Aware Date: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention