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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 865211
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Edema (1820); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event 03/13/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient experienced pain and intraoral infection.Their dental implant was explanted six years after initial placement.An edema, inflammation, and osteopenia were also reported.
 
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Brand Name
LEGACY 3 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8520279
Report Number3001617766-2019-00162
Device Sequence Number1612205
Product Code DZE
UDI-Device Identifier10841307102649
UDI-Public10841307102649
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 04/16/2019
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 Date04/24/2017
Device Catalogue Number865211
Device Lot Number35908
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/18/2019
Initial Report FDA Received Date04/16/2019
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 Age43 YR
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