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

Model Number	08674
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
Doctor indicated fracture of locator abutment.One screw piece got stuck in implant.Patient was rescheduled for implant removal.
Event or Problem Description
Doctor indicated fracture of locator abutment.One screw piece got stuck in implant.Patient was rescheduled for implant removal.

• 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 Key: 8765364
• Report Number: 2023950-2019-00360
• Device Sequence Number: 1977680
• Product Code: NHA
• UDI-Device Identifier: 00840481100376
• UDI-Public: 00840481100376
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• 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 Number: 08674
• Device Catalogue Number: N/A
• Device Lot Number: I1EK9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention