MAUDE Adverse Event Report: ZEST ANCHORS, LLC; LOCATOR IMPLANT ATTACHMENT SYSTEM

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2017

Event Type  Injury  

Event Description

The distributor reported that the locator screw fractured inside the implant.The dentist is unable to remove the fracture part of abutment from the implant.

• Type of Device: LOCATOR IMPLANT ATTACHMENT SYSTEM
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: lin ; 2875 loker avenue east; carlsbad, CA 92010 ; 7607437744
• MDR Report Key: 7202676
• MDR Text Key: 97633813
• Report Number: 2023950-2017-00579
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K9942157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Device Operator: Dentist
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/17/2018
• 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