Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 854213
Medical Device Problem Codes Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Insufficient Information (4580)
Date of Event 01/26/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, broken or fractured component was observed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11341401
Report Number3001617766-2021-01296
Device Sequence Number4997842
Product Code DZE
UDI-Device Identifier10841307102816
UDI-Public10841307102816
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 03/25/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date03/18/2020
Device Catalogue Number854213
Device Lot Number61922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Initial Date Received by Manufacturer 02/02/2021
Supplement Date Received by Manufacturer03/02/2021
Initial Report FDA Received Date02/18/2021
Supplement Report FDA Received Date03/26/2021
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;
Patient Age65 YR
Patient Weight82
-
-