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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 884210
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), during the clinical procedure, upon insertion of the implant, the driver would not disengage from the implant.The implant required backing out and it was separated from the driver with pliers.
 
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Brand Name
LEGACY 4 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8458563
Report Number3001617766-2019-00109
Device Sequence Number14184663
Product Code DZE
UDI-Device Identifier10841307103318
UDI-Public10841307103318
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/25/2023
Device Catalogue Number884210
Device Lot Number118071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/01/2019
Initial Report FDA Received Date03/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age26 YR
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