AO Custom Case Submission

You will be directed to a file upload after this form is completed to upload case files (CT Scans, etc.)

Patient Information

Submission Date

Patient Name (First, Last)

Patient DOB

Patient Gender

Affected Side

Affected Anatomy

Activity Level

Patient Condition/Indication/Rational

Description of Patient Specific Device

Surgical Approach

Is there a Proposed Surgery Date?

*Please note, we recommend waiting to schedule the surgery until after we finalize the implant design, begin manufacturing, and provide an implant availability date via email. We will do our best to accommodate the proposed date and will inform you if we have any concerns.

Implants Involving a Total Talus:

If not, please continue. If yes, please select all that apply.

Will the implant be used with a total ankle tibial component?

Will the subtalar joint be fused?

Will the TN joint be fused?

Will the implant be used with any additional hardware?

Is there any hardware currently in the affected side?

Are there any other disease or neurological considerations that could impact the design or should be considered during the design process?

Please select your desired implant material

Implants Involving a Hindfoot Cage / Segmental Defect:

Please select all that apply.

Would you like the proximal cage interface for the tibia to be:

Would you like the distal interface with the calcaneus to be:

Is restoring height/length important to the design?

Would you consider staging this patient for optimal implant placement?

(i.e. Circular frame, ex-fix)

If removing the talar head, would you like

How much distraction do you think you can achieve, if needed?

Implants Involving the Forefoot / MTP:

Please select all that apply.

Do you prefer the interface for a distal/proxima

If requesting a cage/plate construct, do you prefer:

Are you open to using the following options within the design if appropriate

Are there any other disease or neurological considerations that could impact the design or should be considered during the design process?

Sales Rep Information

Sales representative (First, Last)

Please write 'na' if you do not know

Surgeon Information

Surgeon Name (First, Last)

Surgeon Email

1️⃣ Hospital/Facility Name

NPI Number

Look up surgeon NPI here https://npidb.org/

City

State

Zip Code

Surgeon Signature

I Accept

By selecting the "I Accept" button, you are signing this form electronically. You agree your electronic signature is the legal equivalent of your manual signature on this form.

I Accept

Attention

This is a custom device designed to comply with the specific requirements you have requested. Custom devices are exempt from meeting the requirements for premarket approval. For these reasons, Paragon 28, Inc. does not make any claims related to its performance or intended use. The physician requesting this device is responsible for identifying proper use of the device and for any consequences resulting from its use. It is the physician’s responsibility to ensure that the hospital and patient are properly informed of your intent to use a custom device to treat the patient’s disorder. We strongly recommend that you inform the patient of the risks associated with its use. In particular, the risks associated with the absence of biomechanical and clinical performance data. Your signature signifies that you have read and understand the consequences stated above.

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