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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 863713
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier and weight were not provided.When the requested information becomes available, a supplementary report will be submitted.
 
Event or Problem Description
Per (b)(4), during clinical procedure, patient experienced failure of implant to osseointegrate.
 
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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 Key11999402
Report Number3001617766-2021-03525
Device Sequence Number3411166
Product Code DZE
UDI-Device Identifier10841307102472
UDI-Public10841307102472
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
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) 07/16/2021
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 Date11/11/2024
Device Catalogue Number863713
Device Lot Number153960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Initial Date Received by Manufacturer 06/08/2021
Supplement Date Received by Manufacturer07/02/2021
Initial Report FDA Received Date06/15/2021
Supplement Report FDA Received Date07/16/2021
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
Patient Weight79
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