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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL INTAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 2111020
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2015
Event Type  malfunction  
Manufacturer Narrative
Inspection of the involved nail indicated that the valve at nail' proximal end was deformed. It may be that excessive force was applied during the connection of the inflation adapter and the nail. 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. 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 DeviceINTAMEDULLARY 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
herzelia, 46724-11
IS   4672411
MDR Report Key6857286
MDR Text Key85748639
Report Number9615128-2017-00030
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 Date05/31/2019
Device Catalogue Number2111020
Device Lot NumberIHN00344
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 Received01/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2014
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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