FDA Adverse Event
Injury
Summary report: N
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX46MM NON STERILE
MDR report key: 22294358
·
Received June 19, 2025
Report
- Report Number
- 0001649390-2025-00459
- Event Type
- Injury
- Date Received
- June 19, 2025
- Date of Event
- May 24, 2021
- Report Date
- June 19, 2025
- Manufacturer
- TORNIER INC
- Product Code
- PHX
- UDI-DI
- 00846832089819
- PMA / PMN Number
- K161742
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT IS STATUS POST RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. ONE OF THE SCREWS FROM THE IMPLANTS CAME LOOSE AND FRACTURED THE SCAPULA, CAUSING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864028 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX46MM NON STERILE | SHOULDER PROSTHESIS, REVERSE CONFIGURATION | PHX | TORNIER INC | UNKNOWN | 00846832089819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Other |