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

Model Number 90434

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the surgeon, the patient experienced recurrent infection and skin overgrowth at the abutment site.The implanted device remains.Revision surgery is planned to remove the abutment, but has not yet occurred as of the date of this report.

Event Description

Per the clinic, the abutment was removed on (b)(6) 2021 under general anesthesia.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• 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: 11632380
• MDR Text Key: 244370541
• Report Number: 6000034-2021-00935
• 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
• Report Date: 05/05/2021,04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: 011CMC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Distributor Facility Aware Date: 04/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention