FDA Adverse Event
Injury
Summary report: N
CUSTOM RTSA
MDR report key: 23816315
·
Received December 16, 2025
Report
- Report Number
- 3014833750-2025-00022
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- January 3, 2025
- Report Date
- December 15, 2025
- Manufacturer
- RESTOR3D, INC.
- Product Code
- PHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PATIENT PRESENTED INITIALLY WITH EXTENSIVE DAMAGE TO THE HUMERUS REQUIRING A CUSTOMIZED, EXTENSIVE RECONSTRUCTION. THE SURGEON APPROVED THE DESIGN AND POSITIONING OF THE DEVICE, AND ACKNOWLEDGED THE RISK OF CUSTOM DEVICE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED, AND THE REVISION PROCEDURE WILL MAINTAIN THE HARDWARE IN QUESTION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HUMERAL STEM LOOSENING, AND THE SURGEON HAS SCHEDULED A REVISION TO CORRECT IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2281700 | CUSTOM RTSA | REVERSE TOTAL SHOULDER REPLACEMENT | PHX | RESTOR3D, INC. | 11784-100 | M-074 11784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |