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

Model Number 92129

Device Problem Osseointegration Problem (3003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 14, 2017.(b)(4).

Event Description

Per the clinic, the patient experienced a loss of osseointegration (date not reported).

• 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
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6790956
• MDR Text Key: 82555757
• Report Number: 6000034-2017-01554
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1078121(17)211017
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2021
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH1078121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: No
• 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