MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM & BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129 & 93357

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced a loss of osseointegration.The patient will be re-implanted in a few month time.

• Brand Name: BI300 IMPLANT 4 MM & BA300 ABUTMENT 12MM
• 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
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9000132
• MDR Text Key: 158602370
• Report Number: 6000034-2019-01755
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92129 & 93357
• Device Catalogue Number: 92129 & 93357
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention