This form must be completed for all complaints about the iFuse Implants and instruments as well as for all revision surgeries including the removal or adjustment of iFuse Implants or addition of iFuse Implants to an existing iFuse construct.
Make sure you have gathered all of the applicable information before filling out the form. This form will time out if not completed.
This information is used to create the complaint report and to determine if a reportable adverse event has occurred. Protected patient health information may be provided to the company for the purposes of complaint investigation. Do not include any PHI on this form. Supporting documents containing PHI may be emailed directly to QA@si-bone.com
Please email QA@si-bone.com or call 408-207-0700 if you have any questions or need assistance.
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