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

Model Number	01731-SB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abutment fracture.Fracture of 1 locator.The fragments could not be removed.The implant (ankylos c/x implant a8) is no longer restorable and had to be removed.
Event or Problem Description
Abutment fracture.Fracture of 1 locator.The fragments could not be removed.The implant (ankylos c/x implant a8) is no longer restorable and had to be removed.

• Brand Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• 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: 23458734
• Report Number: 2023950-2025-00203
• Device Sequence Number: 13054873
• Product Code: NHA
• UDI-Device Identifier: 00840481108730
• UDI-Public: 00840481108730
• 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: 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): 01/08/2026

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: 01731-SB
• Device Catalogue Number: N/A
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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