MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 20MM, FINAL KIT; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number	LATSYS20
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For h6 clinical signs code grid, currently a relevant code is not available in our system to accurately capture the implant migrating hence the appropriate code / term not applicable was chosen.
Event or Problem Description
It was reported the patient with bilateral latera nasal implants experienced expulsion of the right implant within the first week of implant placement.The surgeon has reported the patient performed post procedure manipulation of the nose and patient wore spectacles.Medical intervention was performed and the right nasal implant was explanted from the nasal cavity.The surgeon has planned to re-implant latera on the patient after the explantation site has been healed.Additional information is currently being requested.
Event or Problem Description
The patient was reimplanted on the right nasal anatomy and no further issues have been noted.
Additional Manufacturer Narrative
Follow up report submitted to document additional surgery documented in b5.

• Brand Name: LATERA 20MM, FINAL KIT
• Common Device Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23301418
• Report Number: 3006345872-2025-00012
• Device Sequence Number: 15959594
• Product Code: NHB
• UDI-Device Identifier: 00857037006037
• UDI-Public: (01)00857037006037(17)250430(10)25120063
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: LATSYS20
• Device Lot Number: 25120063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown