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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 07724
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/10/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseo-integrate in the patient's mouth, and had to be removed.(non-integration).
 
Event or Problem Description
Implant failed to osseo-integrate in the patient's mouth, and had to be removed.(non-integration).
 
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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 Key9318313
Report Number2023950-2019-00607
Device Sequence Number398377
Product Code DZE
UDI-Device Identifier00840481108471
UDI-Public00840481108471
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K120198
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer,distributor,health p
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 12/30/2019
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 Number07724
Device Catalogue NumberN/A
Device Lot NumberL0UB6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Initial Date Received by Manufacturer 10/29/2019
Supplement Date Received by Manufacturer10/29/2019
Initial Report FDA Received Date11/13/2019
Supplement Report FDA Received Date12/30/2019
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;
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