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); Pain (1994)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented approximately ten (10) days after a bilateral implant procedure with drainage, tenderness and redness along the lateral nasal wall coincident with the latera absorbable nasal implant on the left side.No problems were reported on the right side of the nose.The physician prescribed antibiotics for 14 days with minimal improvement and noted an active infection in the left side wall of the nose.The implant on the left side was surgically removed in two pieces using a pocket incision starting at the alar rim advancing to the alar crease.The incision was closed with a suture.It was reported at approximately two weeks after implant removal that the infection resolved with no further sequelae.

• 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: 7068550
• Report Number: 3011238988-2017-00006
• Device Sequence Number: 156124
• Product Code: NHB
• UDI-Device Identifier: 00857037006044
• UDI-Public: (01)00857037006044
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: 51 YR
• Patient Weight: 113