MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Loss of Osseointegration (2408)

Patient Problem Head Injury (1879)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2017, by (b)(4).

Event Description

Per the clinic, the patient experienced a loss of osseointegration on (b)(6) 2017, subsequent to sustaining a head injury.Clinical management is ongoing.

• Brand Name: BI300 IMPLANT 3MM
• 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: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6580830
• MDR Text Key: 75594896
• Report Number: 6000034-2017-00970
• 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: Audiologist
• Type of Report: Initial
• Report Date: 05/02/2017

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: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH888447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 10 YR