FDA Adverse Event
Malfunction
Summary report: N
NEXTRA
MDR report key: 21679313
·
Received March 24, 2025
Report
- Report Number
- 3009540749-2025-00003
- Event Type
- Malfunction
- Date Received
- March 24, 2025
- Manufacturer
- MEDARTIS INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 0
IMPLANT DID NOT LOCK IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458889 | NEXTRA | NEXTRA | HWC | MEDARTIS INC. | NX-4532K, NX-4532MP | 168121623A, 168220323B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |