MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90434

Device Problem Loss of Osseointegration (2408)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is filed on on november 10, 2016.Implanted device remains.

Event Description

Per the clinic, the patient experienced a loss of osseointegration (date not reported).It is unknown if there are plans to re-implant the patient with a new device as of the date of this report, november 10, 2016.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• 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 (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6091773
• MDR Text Key: 59553223
• Report Number: 6000034-2016-02263
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: 001CMC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/02/2016
• Date Manufacturer Received: 11/02/2016
• 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