Import Alert 84-03
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 84-03
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Lyodura (Dura Mater)"
Reason for Alert:
A recent reported case of Creutzfeldt Jakob Disease (CJD) in a 28 year old patient who had received a human dura mater graft indicates that the graft may have been the source of this always fatal disease. The woman died 22 months after receiving the lyophilized, irradiated human cadaveric dura mater graft. The dura mater used in the graft was packaged in October 1982 under lot #2105 by B. Braun Melsungen AG of West Germany, shipped to Tri Hawk International, Inc., Montreal, Quebec, Canada and sold to Saint Francis Hospital, Hartford, Connecticut, on April 4, 1985.
This is the first known case of CJD transmission associated with a dura mater graft. Present methods of sterilizing the dura mater do not completely inactivate the CJD agent.
The dura mater is manufactured by the West German firm under the trade name Lyodura. Although the material is primarily used in neurosurgery, it is also used in orthopedic, otologic, dental, urologic, gynecologic, and cardiac surgical procedures.
We have been unable to determine the total number of packages of Lyodura that were imported into the United States because the Canadian distributor failed to maintain adequate records of distribution for all lots which may have been distributed by mail to hospitals in the United States and Canada.
As stated in the FDA Safety Alert which issued April 28, 1987, we strongly recommend that users of dura mater choose only products from known sources which retrieve, process and handle the material according to guidelines such as those of the American Association of Tissue Banks.
This is the first known case of CJD transmission associated with a dura mater graft. Present methods of sterilizing the dura mater do not completely inactivate the CJD agent.
The dura mater is manufactured by the West German firm under the trade name Lyodura. Although the material is primarily used in neurosurgery, it is also used in orthopedic, otologic, dental, urologic, gynecologic, and cardiac surgical procedures.
We have been unable to determine the total number of packages of Lyodura that were imported into the United States because the Canadian distributor failed to maintain adequate records of distribution for all lots which may have been distributed by mail to hospitals in the United States and Canada.
As stated in the FDA Safety Alert which issued April 28, 1987, we strongly recommend that users of dura mater choose only products from known sources which retrieve, process and handle the material according to guidelines such as those of the American Association of Tissue Banks.
Guidance:
Detain all shipments of Lyodura (dura mater) received from Tri Hawk International, Inc., Montreal, Quebec, Canada, or from B. Braun Melsungen AG of West Germany.
Alert your local Customs office to be aware of this import alert and to monitor mail shipments for this product.
Alert your local Customs office to be aware of this import alert and to monitor mail shipments for this product.
Product Description:
Lyodura
Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears to be adulterated under section 501(h), because the methods and controls used for the storage and distribution of Lyodura (dura mater) are not in conformance with current good manufacturing practice requirements under section 520(f)(1)."
OASIS charge code - DEVICE GMP
OASIS charge code - DEVICE GMP
CANADA
Tri Hawk International Inc
Date Published : 09/16/2009
1570 Rue Bane , Saint-Laurent, QC CANADA
84 - - - -- Neurological
Date Published: 09/16/2009
GERMANY
B. Braun Melsungen AG
Date Published : 09/16/2009
Carl Braun Strasse 1 , Melsungen, GERMANY
84 - - - -- Neurological
Date Published: 09/16/2009
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