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, PRODUCT CODE: LXB, PRODUCT CODE: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, PRODUCT CODE: LXB, PRODUCT CODE:LXB Back to Search Results
Catalog Number 92133
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); No Information (3190)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced skin overgrowth and infection at the abutment site.Subsequently, the patient underwent several procedures (specific dates and procedures not reported).On (b)(6) 2014 the patient was again administered general anesthesia to facilitate the placement of a cover screw.The implanted device remains.
 
Manufacturer Narrative
(b)(4).Implanted device remains.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 22
SW  435 22
Manufacturer Contact
jennifer campo
13059 east peakview ave.
centennial, CO 80111
3037909010
MDR Report Key4341677
MDR Text Key5222336
Report Number6000031-2014-01793
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Audiologist
Type of Report Initial
Report Date 12/05/2014
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 Number92133
Device Lot NumberCOH505087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2014
Initial Date FDA Received12/18/2014
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 Number1
Patient Outcome(s) Required Intervention;
-
-