MAUDE Adverse Event Report: restor3d, inc. restor3d MTP implant; Metatarsophalangeal Hemiarthroplasty

Model Number	1103-161620
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proof-of-sterilization stickers on mtp hemiarthroplasty implants were orange in color, rather than red which indicates exposure to sterilant.The implants were not used and the surgeon converted to a different size of the same product line.
Additional Manufacturer Narrative
The two devices reported as part of this adverse event are the same size and part of the same production lot.The implants in question were not used and the patient was converted to the next available size.No patient harm has been reported at this time.The medwatch filing will be updated with any new information as appropriate.

• Brand Name: restor3d MTP implant
• Common Device Name: Metatarsophalangeal Hemiarthroplasty
• 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 prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 50694566
• Report Number: 3014833750-2026-00054
• Device Sequence Number: 13165359
• Product Code: KWD
• UDI-Device Identifier: 00840097505244
• UDI-Public: 00840097505244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 1103-161620
• Device Lot Number: A02979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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