MAUDE Adverse Event Report: RESTOR3D, INC N/A; REVERSE TOTAL SHOULDER

Model Number	LUTTOND_XC1P8-100
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
2.5 year post-op x-ray appears with broken screw and broken post.Doctor stated patient has been doing a lot of weight-bearing exercises which may have attributed to the failure.
Additional Manufacturer Narrative
The baseplate implant and assembled screw broke about 2 years post-operatively.The surgeon stated the patient was performing "high impact" activities such as pilates.The patient will require a revision surgery to remove the broken implant, but the surgeon reports the patient is currently safe and still has almost full range of motion.Restor3d analysis shows the part was designed and reviewed as intended.Independently from this failure, restor3d previously increased the post core diameter in (b)(6) 2023 from 3.86mm to 4.7mm.

• Brand Name: N/A
• Common Device Name: REVERSE TOTAL SHOULDER
• Manufacturer (Section D): 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: 23458737
• Report Number: 3014833750-2025-00016
• Device Sequence Number: 12348129
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/27/2025

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?: Yes
• Device Model Number: LUTTOND_XC1P8-100
• Device Lot Number: 20230106-DMP-D-01
• 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: 10/27/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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: 74 YR
• Patient Sex: Female