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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 824706
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 08/18/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4) during post operative check, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated a1 for patient information to include ni for no information available.Updated section b4 for report submission date and b6 to report device evaluation results.Section d6, no information was available.Updated g1-g2 for follow-up report submitter, g4 for awareness date and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.This report is submitted late and is captured within capa-1374.
 
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Brand Name
LEGACY 2 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9392155
Report Number3001617766-2019-05545
Device Sequence Number1672271
Product Code DZE
UDI-Device Identifier10841307101352
UDI-Public10841307101352
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
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) 04/29/2020
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 Date03/29/2022
Device Model Number824706
Device Catalogue Number824706
Device Lot Number91776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Initial Date Received by Manufacturer 11/13/2019
Supplement Date Received by Manufacturer12/03/2019
Initial Report FDA Received Date11/30/2019
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 Age48 YR
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