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)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Describe event or problem: it was reported that the patient underwent a bilateral latera absorbable nasal implant procedure and then, about three weeks later presented with redness and swelling on the right side.Topical and systemic (oral) antibiotics were prescribed.The condition was noted to be improved at the follow up visit approximately two weeks later.A follow-up report indicated that the patient's condition had worsened at two months after implant, with pus seeping from the implant area on the right side.The implant on the patient's right side was surgically removed approximately two months post implantation to address the infection.The infection resolved and the implant on the left side remains implanted.

• 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: 6645613
• Report Number: 3011238988-2017-00003
• Device Sequence Number: 1082121
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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 Expiration Date: 02/10/2018
• Device Model Number: LATANI02
• Device Lot Number: 193343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 06/15/2017
• 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: 44 YR
• Patient Weight: 84