MAUDE Adverse Event Report: restor3d, inc. Veritas Shoulder System; Reverse Total Shoulder Replacement

Model Number	3500-340U1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Veritas Shoulder System
• Common Device Name: Reverse Total Shoulder Replacement
• 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: 50954585
• Report Number: 3014833750-2026-00061
• Device Sequence Number: 13136374
• Product Code: PHX
• UDI-Device Identifier: 00840097513522
• UDI-Public: 00840097513522
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243643
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 3500-340U1
• Device Lot Number: A02926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• 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