MAUDE Adverse Event Report: RESOTR3D, INC. CUSTOM HUMERUS RECONSTRUCTION; PROXIMAL HUMERUS PROSTHESIS

Model Number	3500-140C1, 15919-110
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records revealed no abnormalities and no indication of material or manufacturing issues were found during the investigation.
Event or Problem Description
The patient returned approximately 3 weeks following surgery with dislocation of the shoulder.The surgeon revised the patient the following week and confirmed the poly was dissociated from the proximal humeral stem.

• Brand Name: CUSTOM HUMERUS RECONSTRUCTION
• Common Device Name: PROXIMAL HUMERUS PROSTHESIS
• Manufacturer (Section D): RESOTR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27705
• Manufacturer (Section G): RESTOR3D, INC.
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 24911653
• Report Number: 3014833750-2026-00005
• Device Sequence Number: 18598939
• Product Code: PHX
• UDI-Device Identifier: 00840097513430
• UDI-Public: 00840097513430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3500-140C1, 15919-110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male