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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 904106
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Edema (1820); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Swelling (2091); Osteopenia/ Osteoporosis (2651)
Date of Event 11/13/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), patient presented with inflammation and swelling of the implant.Patient condition of peri-implantitis required extraction of the implant.
 
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Brand Name
SWISHPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8600317
Report Number3001617766-2019-00218
Device Sequence Number2339119
Product Code DZE
UDI-Device Identifier10841307105862
UDI-Public10841307105862
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 05/10/2019
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 Date02/08/2016
Device Catalogue Number904106
Device Lot Number30000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/11/2019
Initial Report FDA Received Date05/10/2019
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;
Patient Age58 YR
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