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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 2 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 2 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 827010U
Medical Device Problem Codes Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930)
Date of Event 03/26/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient experienced an intraoral infection.During clinical procedure, the implant driver got stuck inside their dental implant.The implant was removed.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.
 
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Brand Name
SIMPLY LEGACY 2 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8558661
Report Number3001617766-2019-00195
Device Sequence Number11314426
Product Code DZE
UDI-Device Identifier10841307107606
UDI-Public10841307107606
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 06/11/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date07/30/2023
Device Catalogue Number827010U
Device Lot Number120663
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Initial Date Received by Manufacturer 03/28/2019
Supplement Date Received by Manufacturer05/16/2019
Initial Report FDA Received Date04/26/2019
Supplement Report FDA Received Date06/11/2019
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 Age73 YR
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