Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All

SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover. To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods: Mail provided postage paid envelope Fax 610-251-9005 Scan/e-mail to [email protected] For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.