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  

Manufacturer Narrative

This report is submitted on april 23, 2021.

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.

Manufacturer Narrative

Per the surgeon, patient experienced an infection around the abutment site.This report is submitted on june 10, 2021.

• 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: 11713663
• MDR Text Key: 246992698
• Report Number: 6000034-2021-01098
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR