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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
Model Number 877008
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inflammation (1932); Pain (1994)
Date of Event 11/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure,patient experienced failure of implant to integrate.
 
Additional Manufacturer Narrative
This report is submitted late and is captured within capa-1374.
 
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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 Key9465220
Report Number3001617766-2019-05751
Device Sequence Number11762187
Product Code DZE
UDI-Device Identifier10841307103141
UDI-Public10841307103141
Combination Product (Y/N)N
Initial Reporter StatePA
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,Followup
Report Date (Section B) 04/29/2020
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 Date12/27/2023
Device Model Number877008
Device Catalogue Number877008
Device Lot Number131452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Initial Date Received by Manufacturer 11/20/2019
Supplement Date Received by Manufacturer01/06/2020
Initial Report FDA Received Date12/13/2019
Supplement Report FDA Received Date04/29/2020
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 Age63 YR
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