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 Codes	Unspecified Infection (1930); Swelling (2091); Ulcer (2274)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts were made to contact the physician regarding patient status.If further information is received at a later date a supplemental report will be sent.
Event or Problem Description
It was reported that the patient underwent a latera absorbable nasal implant procedure and then, about 6 months post-procedure presented with redness and swelling along the area of the implant and an ulcer on the area over the lower lateral cartilage on one side.The implant was suspected to be 'poking' almost through the lower lateral cartilage.Surgical removal of the infected implant was attempted unsuccessfully as it was difficult to feel the location of the implant.Topical and systemic steroids were prescribed.No further information is available at this time regarding patient status.

• Brand Name: LATERA ABSORBABLE NASAL IMPLANT
• Common Device Name: LATERA ABSORBABLE NASAL IMPLANT
• Manufacturer (Section D): SPIROX, INC.; 595 penobscot drive; redwood city CA 94063
• MDR Report Key: 6732381
• Report Number: 3011238988-2017-00004
• Device Sequence Number: 19175322
• Product Code: NHB
• UDI-Device Identifier: 00857037006044
• UDI-Public: (01)00857037006044
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: Health Professional
• Device Model Number: LATANI02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/21/2017
• 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