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 Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the patient presented 2 weeks post-op with an extrusion of a fractured piece of the nasal implant.The piece that was extruded was removed during an additional procedure.The other piece remains in the patient.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
H3 other text : unknown if fractured piece is available for evaluation.
Event or Problem Description
The user facility reported that the patient presented 2 weeks post-op with an extrusion of a fractured piece of the nasal implant.The piece that was extruded was removed during an additional procedure.The other piece remains in the patient.Although requested, no additional information could be obtained.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : device not available.

• 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: 17926798
• Report Number: 3006345872-2023-00010
• Device Sequence Number: 20526457
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/06/2024
• 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