MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93550

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  Injury  

Event Description

Per the surgeon, it was reported that the patient underwent explant surgery on (b)(6) 2023, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the internal magnet was removed.Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 18271800
• MDR Text Key: 329773578
• Report Number: 6000034-2023-04156
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023,11/13/2023

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: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2023
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male