Titan Spine's Endoskeleton® Device Warranty Summary of Terms and Conditions of Titan Spine's Standard Limited Warranty Agreement

The following is a summary of the key terms and conditions of the standard Limited Warranty Agreement offered by Titan Spine to hospitals, surgery centers and other health care facilities that purchase Titan Spine's products. Please note that warranty coverage is not available in the absence of a signed Limited Warranty Agreement between Titan Spine and any entity purchasing Titan Spine's products.
Titan Spine's Endoskeleton® Device Warranty

Definitions:




  • “Titan Spine” means Titan Spine, LLC.

  • “Purchaser” means a hospital, surgery center or other healthcare facility that has executed a Limited Warranty Agreement with Titan.

  • “Products” means the implant devices for use in spinal fusion surgeries manufactured and sold by Titan and known as the Endoskelton® TA, Endoskeleton® TAS, Endoskeleton® TO, Endoskeleton® TC, Endoskeleton® TT, Endoskeleton® TL, Endoskeleton® TCS, nanoLOCK® TA, nanoLOCK® TAS, nanoLOCK® TO, nanoLOCK® TC, nanoLOCK® TT, nanoLOCK® TL, and nanoLOCK® TCS.

  • "Eligible Product” means a Product which is purchased by a Purchaser (defined below), and which is implanted in a patient before the expiration date set forth in such Product’s packaging.

  • “Warranty Period” means the period starting on the date which is one hundred eighty (180) days after the implantation of the Eligible Product in a patient and ending on the date which is five (5) years after the implantation of the Eligible Product in the patient.



Warranty



Titan Spine will provide a Purchaser a one-time free replacement of any Eligible Product if revision surgery is required within the Warranty Period: (i) because of non-union for any reason other than the failure of the patient to follow post-operative instructions (including but not limited to post-operative instructions relating to limitations on physical activity); (ii) (ii) as a result of clinical evidence of delamination; or (iii) as a result of clinical evidence of generation of particulate debris during implantation. In cases where more than one Eligible Product is implanted into a single disc space, the Warranty entitles Purchaser to the free replacement of any Eligible Product implanted into such single disc space upon the non-union of any other Eligible Product implanted in the same disc space (except in cases where the failure is due to the patient not following post-operative instructions), if the revising surgeon determines the replacement of such Eligible Product is medically necessary. This Warranty is limited to no more than a one-time free replacement of any Eligible Product per patient up to two (2) vertebral levels per surgical case.



If the revising physician elects to utilize an alternative interbody spinal fusion device provided by another party, the Purchaser will receive a credit up to the cost of the replacement device but not to exceed the amount of the original payment made to the Company by the Purchaser for the Eligible Product originally implanted into the patient. The credit will be awarded to the Purchaser within thirty (30) calendar days after a Warranty claim is made by the Purchaser in accordance with the procedures described below.



Claim Procedure



In order to receive the benefits of the Warranty, the Purchaser must, within five (5) business days after the revision surgery wherein the Eligible Product was replaced, submit a fully-completed written Claim Form to Titan on a form provided by Titan. Purchaser may request a Claim Form by contacting Titan’s warranty department by telephone at (866) 822-7800, by e-mail at TSWarranty@titanspine.com or by secure fax to (262) 289-1272. In all cases, the Claim Form shall be accompanied by a copy of the original receipt or invoice for the Eligible Product for which replacement is sought.  If the revision surgery was required as a result of non-union, the Claim Form shall also be accompanied by (i) a CT scan report demonstrating non-union, as determined by an independent radiologist mutually acceptable to the parties; and (ii) a written report from the revising surgeon describing the non-union and certifying that the non-union was not a result of the failure of the patient to follow post-operative instructions (including but not limited to post-operative instructions relating to physical activity). If the revision surgery was required as a result of delamination or implantation-related particulate debris generation, the Claim Form shall also be accompanied by documentation reasonably acceptable to Titan substantiating such delamination or particulate debris. If Purchaser is claiming warranty coverage for more than one Eligible Product implanted into a single disc space, the Claim Form shall be accompanied by a certification from the revising physician that the replacement of all Eligible Products for which the warranty claim is being made was medically necessary.



Reimbursement of Costs



In cases covered by the Warranty, the cost of shipment of the revised Eligible Product to Purchaser shall be reimbursed to the Purchaser by Titan within a reasonable period of time after receipt of invoice.