MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92127

Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problems Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced swelling at the implant site and was subsequently treated with topical antibiotics (specific date and duration not reported).Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (specific date not reported).The patient was placed under general anesthesia in order to be reimplanted with another cochlear device on (b)(6) 2022.

• Brand Name: BA400 ABUTMENT 6MM
• 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: 15367630
• MDR Text Key: 299353119
• Report Number: 6000034-2022-02571
• 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: 10/20/2022,09/27/2022

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: 92127
• Device Catalogue Number: 92127
• 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: 10/20/2022
• Distributor Facility Aware Date: 09/27/2022
• Date Report to Manufacturer: 09/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female