MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92131

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 05/17/2021

Event Type  Injury  

Event Description

Per the clinic, the patient experienced chronic infection at the abutment site, and was treated with oral and topical antibiotics (specific date and duration not reported).The patient was placed under a general anesthetic on (b)(6) 2021, in order to remove the abutment.

Event Description

Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2021, in order to convert the patient to a transcutaneous osia implant system.During the procedure, an implant was placed on the internal fixture.

• Brand Name: BA300 ABUTMENT 9MM
• 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
• MDR Report Key: 12038159
• MDR Text Key: 257372649
• Report Number: 6000034-2021-01955
• 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,Followup
• Report Date: 12/28/2021,12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92131
• Device Catalogue Number: 92131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2021
• Distributor Facility Aware Date: 12/02/2021
• Date Report to Manufacturer: 12/02/2021
• 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