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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 3 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 854216U
Medical Device Problem Codes Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Edema (1820); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932)
Date of Event 11/24/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per (b)(4), a patient experienced infection that could not be treated effectively with antibiotics.Their dental implant was removed and a graft was performed.Inflammation, wound dehiscence, and an edema were also reported.The dental implant was removed one month after initial placement.
 
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Brand Name
SIMPLY LEGACY 3 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e. hillcrest dr.
thousand oaks CA 91362
MDR Report Key8191016
Report Number3001617766-2018-00384
Device Sequence Number13943499
Product Code DZE
UDI-Device Identifier10841307107835
UDI-Public10841307107835
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 12/21/2018
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 Date11/02/2022
Device Catalogue Number854216U
Device Lot Number102982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/27/2018
Initial Report FDA Received Date12/21/2018
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;
Patient Age80 YR
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