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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY3 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 855216
Medical Device Problem Codes Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975); Inaccurate Information (4051)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event 06/22/2018
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), cap is incorrectly labeled as part #: 835216.This malfunction was found internally.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.(b)(4).
 
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Brand Name
LEGACY3 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7723793
Report Number3001617766-2018-00175
Device Sequence Number1370313
Product Code DZE
UDI-Device Identifier10841307102267
UDI-Public10841307102267
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number855216
Device Lot Number110350
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 06/22/2018
Supplement Date Received by Manufacturer07/19/2018
Initial Report FDA Received Date07/26/2018
Supplement Report FDA Received Date08/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		3001617766007202018007R
Patient Sequence Number1
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