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	Abscess (1690)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date and lot number is not known at this time.However, should it become available, it will be provided in future reports.
Event or Problem Description
It was reported that a patient presented approximately six (6) weeks after a bilateral implant procedure with an abscess along the left lateral nasal wall coincident with the forks of the latera absorbable nasal implant.No problems were reported on either side of the nose during the two-week post implantation follow-up visit or on the right side of the nose at six (6) weeks post implantation.The physician incised and drained the abscess and packed the wound, with the implant in situ.When the physician removed the packing the implant forks came out with the packing material.At approximately eight (8) weeks post implantation the patient returned for follow up with some swelling.The physician removed the remainder of the implant, which had migrated superiorly.

• 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: 7146705
• Report Number: 3011238988-2017-00007
• Device Sequence Number: 19074054
• Product Code: NHB
• UDI-Device Identifier: 00857037006044
• UDI-Public: (01)00857037006044
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/26/2017

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: 11/28/2017
• Initial Report FDA Received Date: 12/26/2017
• 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: 57 YR
• Patient Weight: 73