• 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 N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 09/17/2015
Event Type  Injury  
Manufacturer Narrative

This report is filed june 7, 2016. Device not available for analysis.

 
Event Description

Per the clinic, the patient was prescribed oral antibiotics on (b)(6) 2015.

 
Manufacturer Narrative

Correction: the patient was administered oral antibiotics prophylactically, no serious injury occurred. This report is filed july 8, 2016.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLANGE FIXTURE AND ABUTMENT
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, se 435-2 2
SW 435-22
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5706089
MDR Text Key46789197
Report Number6000034-2016-01185
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK984162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue Number93331
Device LOT Number166997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/08/2016 Patient Sequence Number: 1
-
-