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 Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction

• 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): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 25907863
• Report Number: 3015967359-2026-99450
• Device Sequence Number: 8476637
• Product Code: NHB
• UDI-Device Identifier: 00857037006037
• UDI-Public: 00857037006037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: LATSYS20
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown