MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93334

Device Problem Insufficient Information (3190)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection around the abutment site (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.This report is submitted on march 10, 2023.

Manufacturer Narrative

There is now a reported conversion to attract under a general anaesthetic.This report is submitted on april 13, 2023.

• Brand Name: BA400 ABUTMENT 8MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsv[?]gen 14; m[?]lnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: belinder gill ; konstruktionsv?gen 14; no.8 jalan kerinchi; m?lnlycke, 435 3-3 ; SW 435 33
• MDR Report Key: 16519948
• MDR Text Key: 311035997
• Report Number: 6000034-2023-00706
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022743
• UDI-Public: (01)09321502022743(10)142765(17)180930
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 93334
• Device Catalogue Number: 93334
• Device Lot Number: 142765
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female