MAUDE Adverse Event Report: restor3d, inc. Custom Proximal Humerus Reconstruction, reverse configuration

Model Number	3500-536U3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who had received a custom proximal humerus reconstruction reported experiencing a dislocation during physical therapy.The physician was not able to perform a closed reduction of the shoulder, so performed a surgery to correct it.It was discovered intraoperatively that the locking mechanism of the polymer liner had been damaged and had disassociated from the humeral implant.A new liner was implanted.
Additional Manufacturer Narrative
Review of production records associated with the manufacture, packaging, and sterilization of the devices in question reveals no abnormalities.Humeral component dissociations are a common issue in reverse shoulder arthroplasty.

• Brand Name: Custom Proximal Humerus Reconstruction, reverse configuration
• Common Device Name: Custom Proximal Humerus Reconstruction
• 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: 50072912
• Report Number: 3014833750-2026-00031
• Device Sequence Number: 21384229
• Product Code: PHX
• UDI-Device Identifier: 00840097513690
• UDI-Public: 00840097513690
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Device Model Number: 3500-536U3
• Device Lot Number: A03216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown