MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92132

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loose abutment subsequent to sustaining a head injury on (b)(6) 2023.The patient was placed under general anesthesia on (b)(6) 2023, in order to undergo a skin revision and have the abutment replaced.

• Brand Name: BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
• 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: 18062982
• MDR Text Key: 327238653
• Report Number: 6000034-2023-03568
• 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: 11/03/2023,10/13/2023

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: 92132
• Device Catalogue Number: 92132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2023
• Distributor Facility Aware Date: 10/13/2023
• Date Report to Manufacturer: 10/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male