FDA Adverse Event
Injury
Summary report: N
CORTICAL POLYAXIAL SCREW, 7.5MM X 35MM
MDR report key: 18847512
·
Received March 6, 2024
Report
- Report Number
- 3015941638-2024-00003
- Event Type
- Injury
- Date Received
- March 6, 2024
- Date of Event
- February 8, 2024
- Report Date
- March 5, 2024
- Manufacturer
- ASTURA MEDICAL
- Product Code
- OSH
- UDI-DI
- 00841379122944
- PMA / PMN Number
- K153446N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
N/A.
Description of Event or Problem · 0
A SCREW BROKE WHILE IMPLANTED. (POST-OP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117739 | CORTICAL POLYAXIAL SCREW, 7.5MM X 35MM | POLYAXIAL SCREW | OSH | ASTURA MEDICAL | AAPA75035 | 219702C | 00841379122944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention |