SAFETY ALERT

September 14, 2004

Dear Doctor:

Medtronic Sofamor Danek is voluntarily notifying you regarding the use of one of our
products, Bone Graft, that contains bone mmphogenetic protein, 
and an absorbable collagen sponge (ACS). We wanted to inform you about certain
complaints associated with off-label use in anterior cervical fusion procedures that we
have received. Localized soft tissue edema has been reported in anterior cervical
spine fusion surgery following the use of INFUSE Bone Graft. INFUSE Bone
Graft is n_ot approved for use in anterior cervical spine fusion surgery and the safety
and efficacy of INFUSE Bone Graft for this use have n_ot yet been established.

The reported observations occurred within the first post-operative week following
cervical fusion surgery and were transient. Some reports were accompanied by
patient complaints of swelling and difficulty in swallowing and breathing, three of
which resulted in surgical intervention. These reoperations revealed the presence of
edematous tissue with one patient undergoing a tracheotomy. These occasional
complaints have not been associated with neurological deterioration.

Since these complaints have also been reported after cervical surgery without the use
of INFUSE Bone Graft, in the absence of complete data, it is unknown whether these
incidents are solely related to the use of INFUSE Bone Graft. Even though our
investigation is still ongoing, we wanted to apprise you of these reports.

INFUSE Bone Graft is approved for marketing in stand?alone anterior lumbar
interbody spinal fusions when used in conjunction with the Lumbar
Tapered Fusion Device or with certain sizes of INTER FIXTM and INTER FIX RP
Interbody Fusion Devices or (2) after acute open tibial shaft fractures ?xed with
Intramedullary Nails within 14 days. After more than two years of commercial sales,
swelling complaints after on label use in the spine have not been reported. In fact,
this product has an excellent safety record confirming the safety profile established
with extensive pre-clinical testing,

If you have any questions regarding this communication, if you have experienced any

problems with the use of this productour investigation, please
call our Customer Service Department (800-468-9740).

Sincerely,

Richard W. Trehame, 
Sr. Vice President-Regulatory Affairs