MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM WITH BA400 ABUTMENT 10MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 92128 & 93335

Device Problem Loss of Osseointegration (2408)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, abscess presented on (b)(6) 2019 around recipient's abutment and it was treated with oral and topical antibiotics.The recipient experienced loss of osseointegration on (b)(6) 2019 and the clinic will consider reimplantation in 6 months.

• Brand Name: BI300 IMPLANT 3MM WITH BA400 ABUTMENT 10MM
• Type of Device: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 43533 ; SW 43533
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9001006
• MDR Text Key: 158770183
• Report Number: 6000034-2019-01776
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019,08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92128 & 93335
• Device Catalogue Number: 92128 & 93335
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Distributor Facility Aware Date: 08/28/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention