FDA Adverse Event
Malfunction
Summary report: N
LATERA 24MM IMPLANT 2
MDR report key: 23586677
·
Received November 18, 2025
Report
- Report Number
- 3006345872-2025-00014
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- November 12, 2025
- Report Date
- November 18, 2025
- Manufacturer
- ENTELLUS MEDICAL, INC.
- Product Code
- NHB
- UDI-DI
- 00857037006075
- PMA / PMN Number
- K161191
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A FULL UDI IS NOT AVAILABLE DUE TO UNKNOWN LOT/SN.
Description of Event or Problem · 0
IT WAS REPORTED A PATIENT HAS NASAL IMPLANT THAT HAS NOT RESORBED AFTER 2 YEARS WHICH IS CAUSING BULGE ON THE NOSE. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1810318 | LATERA 24MM IMPLANT 2 | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE | NHB | ENTELLUS MEDICAL, INC. | UNKNOWN | 00857037006075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female |