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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPIROX, INC. LATERA ABSORBABLE NASAL IMPLANT
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SPIROX, INC. LATERA ABSORBABLE NASAL IMPLANT Back to Search Results
Model Number LATANI02
Medical Device Problem Codes Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
Date of Event 06/16/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that approximately two (2) days post bilateral lateral implant procedure, the patient experienced pain and yellow and green pus on the right side of the nose and swelling and redness on the left side, coincident with the implants.It was also reported that the physician prescribed augmentin and removed the implant on the right side through the original implantation pierce point.Attempts were made to obtain additional information about the event; no further information was received.
 
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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 Key7748064
Report Number3011238988-2018-00001
Device Sequence Number16415258
Product Code NHB
UDI-Device Identifier00857037006044
UDI-Public(01)00857037006044
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K161191
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/02/2018
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 Date02/01/2019
Device Model NumberLATANI02
Device Lot Number202156
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2018
Initial Report FDA Received Date08/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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