MAUDE Adverse Event Report: RESTOR3D, INC. CUSTOM REVERSE SHOULDER + PROXIMAL HUMERUS RECONSTRUCTION

Model Number	16133-110, 1501-4001, 3500-140C3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced dislocation of the shoulder approximately 3 days after shoulder replacement with proximal humerus reconstruction.A revision surgery took place to implant a larger size of glenosphere to improve soft tissue tension and was successful, though it was noted there was difficulty engaging the poly bearing to the humeral implant.The patient dislocated once again several days later.The device is not available for evaluation.Review of production records reveals no abnormailities for any of the components in question.An appropriate poly size was able to be implanted in the surgery without issue.It is unclear what the root cause may have been that contributed to the reported difficulty.Additional information will be submitted via follow-up as it becomes available and as appropriate.
Event or Problem Description
It was reported that the patient experienced dislocation of the shoulder approximately 3 days after shoulder replacement with proximal humerus reconstruction.A revision surgery took place to implant a larger size of glenosphere to improve soft tissue tension and was successful, though it was noted there was difficulty engaging the poly bearing to the humeral implant.The patient dislocated once again several days later.The device is not available for evaluation.

• Brand Name: CUSTOM REVERSE SHOULDER + PROXIMAL HUMERUS RECONSTRUCTION
• Common Device Name: CUSTOM REVERSE SHOULDER + 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: 25116587
• Report Number: 3014833750-2026-00011
• Device Sequence Number: 10259009
• Product Code: PHX
• UDI-Device Identifier: 00840097513492
• UDI-Public: 00840097513492
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 16133-110, 1501-4001, 3500-140C3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• 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: 62 YR
• Patient Sex: Male