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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR ABUTMENT; ENDOSSEOUS DENTAL IMPLANT
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ZEST ANCHORS, LLC LOCATOR ABUTMENT; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 30506-04
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/14/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Dr.(b)(6) placed abutment (b)(6) 2018, patient came back first week in (b)(6) 2019 with broken /lost abutment.He had to cut the patient's gum with a laser to open up the site to retrieve the threaded part stuck in the implant.
 
Event or Problem Description
Dr.(b)(6) placed abutment on (b)(6) 2018, patient came back first week in (b)(6) 2019, with broken/lost abutment.He had to cut the patient's gum with a laser to open up the site to retrieve the threaded part stuck in the implant.
 
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Brand Name
LOCATOR ABUTMENT
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
ZEST ANCHORS, LLC
2875 loker ave est
carlsbad CA 92010
MDR Report Key8784840
Report Number2023950-2019-00364
Device Sequence Number16654969
Product Code NHA
UDI-Device Identifier00840481112669
UDI-Public00840481112669
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K120198
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 09/06/2019
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 Health Professional
Device Model Number30506-04
Device Catalogue NumberN/A
Device Lot NumberL0HMG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Initial Date Received by Manufacturer 06/20/2019
Supplement Date Received by Manufacturer06/20/2019
Initial Report FDA Received Date07/12/2019
Supplement Report FDA Received Date09/06/2019
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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