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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM

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CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 2111022
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2015
Event Type  malfunction  
Manufacturer Narrative
The involved nail was inspected by the manufacturer, including for its functionality, and was found to be in order. Examination of the production records of the involved 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. Note: this product is no longer marketed in the usa.
 
Event Description
A fixion il humeral nail did not expand during implantation. Another nail was used.
 
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Brand NameFIXION IL HUMERAL 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 street
herzeliya, 46724-11
IS   4672411
MDR Report Key6857283
MDR Text Key85904530
Report Number9615128-2017-00029
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K013449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 05/07/2017
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 Date06/30/2019
Device Catalogue Number2111022
Device Lot NumberIHN00334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2015
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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