MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM, FINAL KIT; LATERA ABSORBABLE NASAL

Model Number	LATSYS24
Medical Device Problem Codes	Expulsion (2933); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
It was reported that the patient had a latera implant procedure on (b)(6) 2020.The patient reported that nearly 2 years later the implant did not dissolve and could still feel the implant through her skin.An additional procedure was performed on (b)(6) 2022 to remove the implant.
Additional Manufacturer Narrative
Corrected data: f10.
Event or Problem Description
It was reported that the patient had a latera implant procedure on (b)(6) 2020.The patient reported that nearly 2 years later the implant did not dissolve and could still feel the implant through her skin.An additional procedure was performed on (b)(6) 2022 to remove the implant.

• Brand Name: LATERA 24MM, FINAL KIT
• Common Device Name: LATERA ABSORBABLE NASAL
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16538036
• Report Number: 3006345872-2023-00003
• Device Sequence Number: 15034114
• Product Code: NHB
• UDI-Device Identifier: 00857037006075
• UDI-Public: 00857037006075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: LATSYS24
• Device Catalogue Number: LATSYS24
• Device Lot Number: 217233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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