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  

Manufacturer Narrative

This report is submitted on november 14, 2023.

Event Description

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

Manufacturer Narrative

Per the clinic, it was reported that the patient was treated with oral and topical antibiotics (specific date and duration not reported).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 (b)(6) 2024.

• Brand Name: BA400 ABUTMENT 8MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18128031
• MDR Text Key: 327990147
• Report Number: 6000034-2023-03658
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93334
• Device Catalogue Number: 93334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• 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