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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT
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ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 07457
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Both implants have broken in the apical third.
 
Event or Problem Description
Both implants have broken in the apical third.
 
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Brand Name
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
ZEST ANCHORS, LLC
2875 loker ave east
carlsbad 92010
MDR Report Key11599053
Report Number2023950-2021-00112
Device Sequence Number14566642
Product Code DZE
UDI-Device Identifier00840481101533
UDI-Public00840481101533
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K120198
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer,distributor,health p
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 04/19/2021
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? No
Operator of Device No Information
Device Model Number07457
Device Catalogue NumberN/A
Device Lot NumberI161D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Initial Date Received by Manufacturer 03/30/2021
Supplement Date Received by Manufacturer03/30/2021
Initial Report FDA Received Date03/31/2021
Supplement Report FDA Received Date04/19/2021
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 Hospitalization; Required Intervention;
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