MAUDE Adverse Event Report: RESTOR3D, INC. VERITAS TOTAL SHOULDER - REVERSE; REVERSE SHOULDER REPLACEMENT

Model Number	1500-1030, 1500-1035
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon investigation following receipt of malfunction information, including review of production records and analysis of information provided by a third party, it was determined that there was a manufacturing deficiency affecting the dimensions of the peripheral screw holes on the subject device.This deficiency creates the potential for improper engagement of the peripheral screws.The devices in question had only been provided to one clinical site during limited market release, and all devices from the affected lots have been returned for disposition.
Event or Problem Description
The surgeon used a compression scrwe with the standard veritas baseplate.While completing final torque, the compression screw pushed through the baseplate.The sales representative noted that the week prior there was a baseplate that has a compression screw seat lower than expected.

• Brand Name: VERITAS TOTAL SHOULDER - REVERSE
• 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
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25778977
• Report Number: 3014833750-2026-00022
• Device Sequence Number: 9633040
• Product Code: PHX
• UDI-Device Identifier: 00840097513225
• UDI-Public: 00840097513225
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1500-1030, 1500-1035
• Device Lot Number: A09828
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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
• Patient Sex: Unknown