FDA Adverse Event
Injury
Summary report: N
ASTURA MEDICAL
MDR report key: 23155980
·
Received September 26, 2025
Report
- Report Number
- 3015941638-2025-00009
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- July 30, 2025
- Report Date
- September 26, 2025
- Manufacturer
- ASTURA MEDICAL
- Product Code
- KWQ
- PMA / PMN Number
- K160702
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PERFORMANCE TESTING OF THE IMPLANTS OF THE IMPLANTS SHOW THEY MEET OUR ESTABLISHED PERFORMANCE REQUIREMENTS.
Description of Event or Problem · 0
SCREW BACKED OUT OF PLATE REQUIRING A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301385 | ASTURA MEDICAL | ACP, 3 LEVEL, 48MM | KWQ | ASTURA MEDICAL | CA3000048 | 789307F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |