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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
Model Number 863210
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 09/18/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
This report is submitted late and is captured within capa-(b)(4).
 
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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 Key9313658
Report Number3001617766-2019-05053
Device Sequence Number11390437
Product Code DZE
UDI-Device Identifier10841307102397
UDI-Public10841307102397
Combination Product (Y/N)N
Initial Reporter CountryJA
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 distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 04/10/2020
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 Date03/01/2022
Device Model Number863210
Device Catalogue Number863210
Device Lot Number89973
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Initial Date Received by Manufacturer 10/23/2019
Supplement Date Received by Manufacturer12/05/2019
Initial Report FDA Received Date11/13/2019
Supplement Report FDA Received Date04/10/2020
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 Age50 YR
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