Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  No Answer Provided  
Manufacturer Narrative
Initial implantation dates and device details not available at the time of this report (b)(6) 2016.Implanted device remains.
 
Event Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.Treatment with injectable steroids (duration not reported) was unsuccessful.Subsequently, the patient underwent revision surgery to remove the excess skin on (b)(6) 2015.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 2 2
SW  435 22
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key5629121
MDR Text Key44328596
Report Number6000034-2016-00856
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K090720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2016
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 Number1
Patient Outcome(s) Required Intervention;
-
-