MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060)

Event Date 03/30/2021

Event Type  Injury  

Event Description

Per the clinic, the patient experienced granulation at the abutment site and was treated with a topical antibiotic (date and duration not reported).On (b)(6) 2021, the patient experienced a loss of osseointegration, resulting in fixture loss.The patient has not yet been reimplanted with a new device as of the date of this report.

Event Description

Per the surgeon, patient experienced an infection around the abutment site.

• Brand Name: BI300 IMPLANT 4 MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 11713625
• MDR Text Key: 246993163
• Report Number: 6000034-2021-01099
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/10/2021,05/18/2021

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: 92129
• Device Catalogue Number: 92129
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2021
• Distributor Facility Aware Date: 05/18/2021
• Date Report to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR