MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

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

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 17, 2023.

Event Description

Per the clinic, the implant magnet was explanted on (b)(6) 2023.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 underwent revision surgery under general anesthesia on (b)(6) 2023, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.This report is submitted on may 29, 2023.

• Brand Name: BI300 IMPLANT 4 MM
• 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: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16563298
• MDR Text Key: 311473424
• Report Number: 6000034-2023-00847
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1135358(17)220816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/16/2022
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH1135358
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2023
• 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 Age: 61 YR
• Patient Sex: Female