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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 07440
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646)
Date of Event 08/17/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Non-integration.Customer states the implants did not osseointegrate and caused pain to the patient.Ultimately extracted the implants via a separate procedure.
 
Event or Problem Description
Non-integration.Customer states the implants did not osseointegrate and caused pain to the patient.Ultimately extracted the implants via a separate procedure.
 
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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 Key12592151
Report Number2023950-2021-00365
Device Sequence Number1547716
Product Code DZE
UDI-Device Identifier00840481129704
UDI-Public00840481129704
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K120198
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 10/13/2021
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 Number07440
Device Catalogue NumberN/A
Device Lot NumberL1NXG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Initial Date Received by Manufacturer 09/28/2021
Supplement Date Received by Manufacturer09/28/2021
Initial Report FDA Received Date10/07/2021
Supplement Report FDA Received Date10/13/2021
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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