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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 Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 03/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The implant failed (did not integrate) in mouth.Patient came in for a 2 month check-up, to check for integration.All implants were integrated except for #22 (07457-s), it was mobile, but there was no pain.Implant was removed because of no integration.
 
Event or Problem Description
The implant failed (did not integrate) in mouth.Patient came in for a 2 month check-up, to check for integration.All implants were integrated except for #22 (07457-s), it was mobile, but there was no pain.Implant was removed because of no 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 CA 92010
MDR Report Key8614312
Report Number2023950-2019-00254
Device Sequence Number16717938
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 Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 07/01/2019
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 Number07457
Device Catalogue NumberN/A
Device Lot NumberL0Q8Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2019
Initial Date Received by Manufacturer 04/18/2019
Supplement Date Received by Manufacturer04/18/2019
Initial Report FDA Received Date05/15/2019
Supplement Report FDA Received Date07/01/2019
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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