MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB, PRODUCT CODE: LXB, PRODUCT CODE:LXB

Model Number 92129

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Blood Loss (2597)

Event Date 12/15/2014

Event Type  Injury  

Event Description

Per the clinic, the patient developed swelling, bleeding and draining at the abutment site.Subsequently, the patient underwent a procedure on (b)(6) 2014 to have the abutment removed and a magnet placed.The implanted device remains.

Manufacturer Narrative

(b)(4).Implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB, PRODUCT CODE: LXB, PRODUCT CODE:LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; molnlycke, se 435 2 2; SW 435 22
• Manufacturer Contact: jennifer campo ; 13059 east peakview ave.; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4426846
• MDR Text Key: 18903337
• Report Number: 6000031-2015-00031
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• 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
• Patient Age: 11 YR