MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Model Number 07461

Device Problem Compatibility Problem (2960)

Patient Problem Failure of Implant (1924)

Event Date 07/05/2018

Event Type  Injury  

Event Description

Doctor indicated non-integration of the implant.

Event Description

Doctor indicated non-integration of the implant.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• 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 Key: 7745338
• MDR Text Key: 115892496
• Report Number: 2023950-2018-00321
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K120198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 07461
• Device Catalogue Number: 07461
• Device Lot Number: I202A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention