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

Model Number 93334

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 1, 2022.

Event Description

Per the clinic, the patient experienced an infection (cellulitis) at the abutment site (treatment unknown).The implant remains in-situ.

Manufacturer Narrative

Per the clinic, the patient was treated with oral antibiotics (specific date and duration not reported).This report is submitted on august 01, 2022.

Manufacturer Narrative

Correction: device details under section d (suspect medical device), was previously reported incorrectly.This has now been updated accordingly.Per the surgeon, the patient was treated with oral and topical antibiotics (specific date and duration not reported).However, the issue could not be resolved.Subsequently, the patient underwent a skin revision surgery to remove the abnormal skin and abutment removal under general anesthesia on (b)(6) 2022.This report is submitted on november 18, 2022.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2023, in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.No other event or complications that may have contributed to the decision to convert the patient were reported.This report is submitted on june 26, 2023.

• Brand Name: BA400 ABUTMENT 8MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 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: mastura ruhanet ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14881883
• MDR Text Key: 295124077
• Report Number: 6000034-2022-01907
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 165862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/18/2022; 10/31/2022; 06/02/2023
• Supplement Dates FDA Received: 08/08/2022; 11/18/2022; 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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