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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/12/2022

Event Type  Injury  

Event Description

Per the clinic, the patient underwent a revision surgery under general anesthesia on (b)(6) 2022 in order to remove the abutment.The implanted device remains.

• Brand Name: NI
• 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: 16143624
• MDR Text Key: 307151993
• Report Number: 6000034-2023-00190
• 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: 01/12/2023,12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2023
• Distributor Facility Aware Date: 12/26/2022
• Date Report to Manufacturer: 12/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male