• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IM TIBIA NAIL INTRAMEDULLARY FIXATION ROD SYSTEM

  • 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
 

CARBOFIX ORTHOPEDICS LTD. FIXION IM TIBIA NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 1213530
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2015
Event Type  malfunction  
Manufacturer Narrative
Examination of the production records of the involve device did not reveal a deviation that may have contributed to the reported case. This report is submitted following an fda inspection at the manufacturer facility. This product is no longer marketed in the usa.
 
Event Description
During implantation of a fixion im tibial nail in (b)(6), the nail did not expand. Another nail was used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIXION IM TIBIA NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzeliya, 46724 11
IS 4672411
Manufacturer (Section G)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim sreet
herzeliya, 46724-11
IS   4672411
MDR Report Key6857292
MDR Text Key85758074
Report Number9615128-2017-00033
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K010901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number1213530
Device Lot NumberF-03409
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-