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

Model Number	01554-SB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fractured locators.Dr.(b)(6), emailed a rep regarding issues with a fixed denture.During this time, two locator® abutments fractured.The case had a slightly long cantilever, which could place lateral forces on the denture and potentially cause fractures in certain parts.It is unclear if the abutments will be returned, but the dentist is requesting credit, as he is not yet sure which implants will be placed in the patient's mouth.
Event or Problem Description
Fractured locators.Dr.(b)(6) emailed a representative regarding issues with a fixed denture.During this time, two locator® abutments fractured.The case had a slightly long cantilever, which could place lateral forces on the denture and potentially cause fractures in certain parts.It is unclear if the abutments will be returned, but the dentist is requesting credit, as he is not yet sure which implants will be placed in the patient's mouth.

• Brand Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad
• Manufacturer Contact: amie toor ; 2875 loker ave e; carlsbad
• MDR Report Key: 22844134
• Report Number: 2023950-2025-00170
• Device Sequence Number: 9305912
• Product Code: NHA
• UDI-Device Identifier: 00840481103889
• UDI-Public: 00840481103889
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Model Number: 01554-SB
• Device Catalogue Number: N/A
• Device Lot Number: L2WBZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown