MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM IMPLANT 2; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number	LATANI24-I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device remains in the patient.
Event or Problem Description
The user facility reported that the patient presented several months post-op with pain and tenderness at the cephalic ends of the implants.The patient reported that they needed new glasses.A follow-up appointment has been scheduled.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
Corrected data: b1, b2, b5; h1 and h6.H3 other text : device remains in the patient.
Event or Problem Description
The user facility reported that the patient presented several months post-op with pain and tenderness at the cephalic ends of the implants.The patient reported that they needed new glasses.After the follow-up appointment the surgeon did not feel that the symptoms were being caused by the implant ¿ the surgeon offered to administer some steroid injections at the site of pain.The patient refused the steroid injection as treatment and was satisfied with the doctors report.No additional surgery was performed, no additional medical intervention was given as a result of the event.

• Brand Name: LATERA 24MM IMPLANT 2
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17926255
• Report Number: 3006345872-2023-00009
• Device Sequence Number: 11506176
• Product Code: NHB
• UDI-Device Identifier: 00857037006068
• UDI-Public: 00857037006068
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LATANI24-I
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/18/2024
• 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