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

Catalog Number LATANI24-I

Device Problems Fracture (1260); Expulsion (2933)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : unknown if fractured piece is available for evaluation.

Event 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.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 325570631
• Report Number: 3006345872-2023-00010
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LATANI24-I
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention