MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Model Number	02792-SB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Abutment broke in patients mouth some time after placement.Doctor had to bring patient in to remove the broken screw thread from the implant.Unsure how long after placement the event occurred.Doctor thinks it broke while getting attachment to correct torque.Fractured abutment.
Event or Problem Description
Abutment broke in patients mouth some time after placement.Doctor had to bring patient in to remove the broken screw thread from the implant.Unsure how long after placement the event occurred.Doctor thinks it broke while getting attachment to correct torque.Fractured abutment.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• 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: 20668858
• Report Number: 2023950-2024-00325
• Device Sequence Number: 7372017
• Product Code: NHA
• UDI-Device Identifier: 00840481109553
• UDI-Public: 00840481109553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 01/16/2025

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: 02792-SB
• Device Catalogue Number: N/A
• Device Lot Number: L31D9
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/16/2025
• 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