Warranty. Titan Spine, LLC (“Titan”) hereby agrees to provide Purchaser a one-time free replacement of any Eligible Product if revision surgery is required within the Warranty Period 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). Titan further agrees to provide Purchaser a one-time free replacement of any Eligible Product if revision surgery is required within the Warranty Period due to clinical evidence of delamination or the generation of particulate debris during implantation.
In cases where more than one Eligible Product is implanted into a single disc space, this 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. Should the physician elect to utilize an alternative interbody spinal fusion device other than that of the Company’s Eligible Product offering, 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 implanted by the physician. The credit will be awarded to the Purchaser within thirty (30) days written notice by the Purchaser confirming the completion of the revised surgical case using an alternative interbody spinal fusion device.
Claim Procedure. In order to receive the benefits of the Warranty under this Agreement, Purchaser must, within five (5) days after the revision surgery wherein the Eligible Product was replaced, (e.g. due to non-union; or due to delamination or implantation-related particulate debris generation), submit a fully-completed written claim form to Titan, and must return the revised Eligible Product to Titan decontaminated by the Purchaser and maintained in a safe, non-destructive manner. The claim form shall be accompanied by: (i) the receipt or invoice for the Eligible Product for which replacement is sought; (ii) a CT scan demonstrating non-union, as determined by an independent radiologist mutually acceptable to the parties or physical evidence of delamination or implantation-related particulate debris generation; and (iii) a written report from the revising surgeon describing the failure and certifying that the failure was not a result of the patient to follow post-operative instructions (including but not limited to post-operative instructions relating to physical activity), and, if Purchaser is claiming warranty coverage for more than one Eligible Product implanted into a single disc space, certifying that the replacement of all Eligible Products for which the warranty claim is being made was medically necessary. Purchaser may request a claim form and instructions for return of Products from its Titan sales representative, or by contacting the manager of Titan’s quality control / regulatory department at (866) 822-7800. In cases covered by the Warranty, the following cost shall be reimbursed to the Purchaser by Titan within a reasonable period of time after receipt of invoice:(A) The cost of shipment of the revised Eligible Product to Purchaser.