MAUDE Adverse Event Report: SPIROX, INC. LATERA ABSORBABLE NASAL IMPLANT

Model Number	LATANI02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of a fullness / sensitivity between the inner canthus and radix of the eye at the location of the implant distal forks.The patient also complained of minor inflammation at this site causing some aesthetic impact.No other eye related issues were recorded by the physician.This was reported in full approximately 2 weeks after implantation.The physician suggested waiting 2 weeks to evaluate the minor aesthetic concerns and sensitivity that is typical of procedures such as this and resolves within 4-6 weeks.No signs of infection were reported and no antibiotics were given prophylactically.Two weeks later, the physician reported that the implant was surgically removed in the clinic at the patient's request based on her continued discomfort.Any aesthetic concerns had resolved completely.The implant was fully intact during the first attempted removal.The physician injected local anesthetic in the lateral wall and made a very small internal marginal incision at the caudal edge of the lower lateral cartilage and dissected a small pocket in the lateral wall with mosquito forceps in a conventional manner.He was unable to locate and retrieve the implant.The physician engaged a facial plastics trained colleague to assist in locating the implant.This physician performed an infra-orbital nerve block to provide prolonged comfort to the patient during the extended procedure and was able to fully remove the implant.The assisting physician commented during the procedure that he believed the implant was irritating a small nasal nerve and that's why the patient could not tolerate it through the acute healing period.The patient later contacted the company and described pain experienced as "extreme" rather than previously reported sensitivity.The discussion with the patient was subsequently summarized with the primary physician and no follow-up notes included complaints of "extreme" pain by the patient.However, the physician was not able to confirm that leaving the implant in place would result in total resolution of pain within a reasonable time period.

• Brand Name: LATERA ABSORBABLE NASAL IMPLANT
• Common Device Name: LATERA ABSORBABLE NASAL IMPLANT
• Manufacturer (Section D): SPIROX, INC.; 3475-o edison way; menlo park CA 94025
• MDR Report Key: 6447322
• Report Number: 3011238988-2017-00001
• Device Sequence Number: 1200316
• Product Code: NHB
• UDI-Device Identifier: 00857037006044
• UDI-Public: (01)00857037006044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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: Physician
• Device Model Number: LATANI02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2016
• Initial Report FDA Received Date: 03/30/2017
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 50