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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 2110026
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2015
Event Type  malfunction  
Manufacturer Narrative
Examination of the involved nail detected a hole in its body membrane. Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case. Based on investigation findings, it seems that the nail was damaged during implantation by a sharp hard object. 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 leaked during implantation in a patient in (b)(6). The nail was replaced during operation in another nail.
 
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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
k013449
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim street
herzeliya, 46724-11
IS   4672411
MDR Report Key6857291
MDR Text Key85904977
Report Number9615128-2017-00031
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 foreign
Type of Report Initial
Report Date 05/08/2017
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 Date06/30/2018
Device Catalogue Number2110026
Device Lot NumberIHN00287
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2015
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2013
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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