FDA Adverse Event
Injury
Summary report: N
LOQTEQ® VA X-PLATE 2.5
MDR report key: 19524708
·
Received June 12, 2024
Report
- Report Number
- 3001406084-2024-00004
- Event Type
- Injury
- Date Received
- June 12, 2024
- Report Date
- June 11, 2024
- Manufacturer
- AAP IMPLANTATE AG
- Product Code
- HRS
- PMA / PMN Number
- K182785
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
DESPITE REPEATED REQUESTS, NO FURTHER INFORMATION ON THE CASE WAS PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE, IT WAS NOT POSSIBLE TO ADEQUATELY ANALYZE THE CAUSES.
Description of Event or Problem · 0
FAILURE OF PLATE OSTEOSYNTHESIS IN THE AREA OF THE TARSUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 372584 | LOQTEQ® VA X-PLATE 2.5 | BONE PLATES | HRS | AAP IMPLANTATE AG | PF 2544-01-2 | K002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Prefer Not To Disclose | Required Intervention |