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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR IMPLANT ATTACHMENT SYSTEM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT
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ZEST ANCHORS, LLC LOCATOR IMPLANT ATTACHMENT SYSTEM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT Back to Search Results
Device Problem Fracture (1260)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
Dr.Indicated the abutment screw fractured.The fractured part of the screw remains inside the implant.Doctor will try to remove it.After confirmed with the distributor, the distributor mentioned the doctor is not able to remove the fractured part and will remove the implant.
 
Event Description
Dr.Indicated the abutment screw fractured.The fractured part of the screw remains inside the implant.Doctor will try to remove it.After confirmed with the distributor, the distributor mentioned the doctor is not able to remove the fractured part and will remove the implant.
 
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Brand Name
LOCATOR IMPLANT ATTACHMENT SYSTEM
Type of Device
ENDOSSEOUS DENTAL IMPLANT ABUTMENT
Manufacturer (Section D)
ZEST ANCHORS, LLC
2875 loker avenue east
carlsbad CA 92010
Manufacturer Contact
david lin
2875 loker avenue east
carlsbad, CA 92010
7607437744
MDR Report Key7136244
MDR Text Key95450323
Report Number2023950-2017-00540
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
PMA/PMN Number
K9942157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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