MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1; EAR, NOSE AND THROAT SYNTHETIC POLYMER MATERIAL

Model Number	LATANI02
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant dissolves.
Event or Problem Description
Three years post implant the latera device is protruding out the side of the patient's nose causing pain and disfigurement.

• Brand Name: LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1
• Common Device Name: EAR, NOSE AND THROAT SYNTHETIC POLYMER MATERIAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• MDR Report Key: 10554253
• Report Number: 3006345872-2020-00007
• Device Sequence Number: 14055985
• Product Code: NHB
• UDI-Device Identifier: 00857037006044
• UDI-Public: 00857037006044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: LATANI02
• Device Catalogue Number: LATANI02
• Device Lot Number: 197638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR