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.

Contact Information

Complaint Details

Revision Surgeries (if applicable)



Please email both the initial surgery and revision surgery RPOs to QA@si-bone.com

Product Information

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Please email any supporting documents to QA@si-bone.com

Initial Surgery

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 any supporting documents to QA@si-bone.com

Revision Surgery (if applicable)

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Please email any attachments to QA@si-bone.com

Notes

This document contains confidential, proprietary information of SI-BONE It may not be copied or reproduced without prior written permission from SI-BONE

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