MAUDE Adverse Event Report: RESTOR3D, INC. AXIOM PSR; TOTAL ANKLE IMPLANTATION SYSTEM

Model Number	5831-9006
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon received the correct anatomic model for case 18059, but the cutting guides that were inside the package belonged to a different case.The surgery was completed successfully and the patient was not affected.
Additional Manufacturer Narrative
The psi cutting guide provided for a case was swapped with the psi cutting guide of another case.Investigation reveals the other case's packaging contains the guide intended for the first case.No devices other than the cutting guides for these two cases are affected.The case was completed to the satisfaction of the surgeon and no known adverse event has taken place.

• Brand Name: AXIOM PSR
• Common Device Name: TOTAL ANKLE IMPLANTATION SYSTEM
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25841686
• Report Number: 3014833750-2026-00026
• Device Sequence Number: 16053798
• Product Code: OYK
• UDI-Device Identifier: 00840097509945
• UDI-Public: 00840097509945
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Replace
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5831-9006
• Device Lot Number: D-788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown