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

Model Number 08765

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Dr.Indicated the abutment screw fractured.The fractured part of the screw remains inside the implant.Doctor may take out the implant.

• 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 Key: 7154928
• MDR Text Key: 96054465
• Report Number: 2023950-2017-00551
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K9942157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 08765
• Device Catalogue Number: 08765
• Device Lot Number: I13ZG
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• 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