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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY4 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY4 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 874706
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Granuloma (1876); Failure of Implant (1924); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 08/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age and sex were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to integrate.
 
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Brand Name
LEGACY4 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key12342040
Report Number3001617766-2021-04960
Device Sequence Number11920612
Product Code DZE
UDI-Device Identifier10841307102953
UDI-Public10841307102953
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
NA
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) 11/03/2021
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 Date12/23/2018
Device Catalogue Number874706
Device Lot Number46746
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/16/2021
Supplement Date Received by Manufacturer11/01/2021
Initial Report FDA Received Date08/19/2021
Supplement Report FDA Received Date11/03/2021
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;
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