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

Catalog Number 92346

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/18/2014

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.The patient underwent a revision surgery to remove the excess skin on (b)(6) 2014.The fixture and abutment remain insitu.

Manufacturer Narrative

(b)(4).Implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 22; SW 435 22
• Manufacturer Contact: rebekka jeger ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 1294286300
• MDR Report Key: 4344239
• MDR Text Key: 5200757
• Report Number: 6000034-2014-01842
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/26/2014

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 Catalogue Number: 92346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/18/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR