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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 804711
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 05/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during post operative check patient experienced failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Device received is different from that which was submitted on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.
 
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Brand Name
LEGACY 1 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9207897
Report Number3001617766-2019-04734
Device Sequence Number305154
Product Code DZE
UDI-Device Identifier10841307102533
UDI-Public10841307102533
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 Year2018
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) 12/12/2019
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? No
Operator of Device Health Professional
Device Expiration Date06/11/2023
Device Catalogue Number804711
Device Lot Number116600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Initial Date Received by Manufacturer 10/09/2019
Supplement Date Received by Manufacturer10/09/2019
Initial Report FDA Received Date10/18/2019
Supplement Report FDA Received Date12/12/2019
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 Age82 YR
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