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

Model Number	3500-140U1; 1506-1001
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: Veritas rTSA
• Common Device Name: Reverse 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: 50724468
• Report Number: 3014833750-2026-00057
• Device Sequence Number: 8862013
• Product Code: PHX
• UDI-Device Identifier: 00840097513409
• UDI-Public: 00840097513409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 3500-140U1; 1506-1001
• Device Lot Number: A04936; A03411
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• 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