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

Model Number	08663
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor indicated fracture of abutment inside patient.Implant was removed.
Event or Problem Description
Doctor indicated fracture of abutment inside patient.Implant was removed.

• Brand Name: LOCATOR ABUTMENT
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• MDR Report Key: 9131424
• Report Number: 2023950-2019-00524
• Device Sequence Number: 19526848
• Product Code: NHA
• UDI-Device Identifier: 00840481101229
• UDI-Public: 00840481101229
• 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: consumer,distributor,health p
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: No Information
• Device Model Number: 08663
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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