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Run: Implant Tracking and Traceability Log

Track each implant case with UDI, lot, manufacturer, and patient record linkage in one audit-ready log. Use it to support recall response, verification, and ...

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Case and Submission Details

Procedure Date (required)

Select the date the implant procedure occurred.

Facility / Site (required)

Enter the facility or site where the implant was used.

Department / Service Line

Optional department or service line for internal tracking.

Submitted By (required)

Name or role of the person completing this log.

Submission Timestamp

System-recorded timestamp for the audit trail.

Patient Record Linkage

Patient Record ID / MRN (required)

Enter the patient medical record number or internal patient record ID used by your organization.

Patient Initials

Optional initials for quick cross-checking when allowed by policy.

Consent / Disclosure Acknowledgment (required)

Confirm that this submission is limited to minimum-necessary patient linkage information and will be used for treatment, operations, compliance, and audit trail purposes.

Yes No N/A

Implant Device Information

Implant Device Name (required)

Enter the commercial or catalog name of the implant.

Manufacturer (required)

Enter the device manufacturer name.

UDI (Unique Device Identifier) (required)

Enter the device UDI exactly as printed on the label or packaging.

Lot Number (required)

Enter the lot or batch number for the implant.

Serial Number

Enter the serial number if the device has one.

Expiration Date

Enter the expiration date if applicable.

Implant Event and Verification

Implant Site / Body Location (required)

Enter the anatomical site where the implant was placed.

Implanting Provider

Optional provider name or role for internal verification.

Verification Method (required)

Select the methods used to verify the implant identifiers before documentation was finalized.

Implant Confirmed as Used (required)

Confirm whether the device was implanted during the case.

Notes / Exceptions

Document any discrepancies, missing identifiers, or special circumstances.

Recall and Follow-Up Readiness

Recall or Safety Alert Flag

Check if the implant is associated with a recall, safety notice, or field correction.

Yes No N/A

Follow-Up Required (required)

Indicate whether any follow-up action is needed due to incomplete data or a device issue.

Follow-Up Owner

Enter the team or role responsible for follow-up if needed.

Follow-Up Due Date

Set a due date when follow-up is required.

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