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

Model Number	02071-NB-SB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Locator broke inside the implant.Customer stated that locator abutment screw broke inside the implant and 3 years after placement and could not retrieve screw so implant removed and replaced with larger diameter.
Event or Problem Description
Locator broke inside the implant.Customer stated that locator abutment screw broke inside the implant and 3 years after placement and could not retrieve screw so implant removed and replaced with larger diameter.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer Contact: amie toor ; 2875 loker ave e; carlsbad, CA 92010
• MDR Report Key: 16801721
• Report Number: 2023950-2023-00135
• Device Sequence Number: 11529106
• Product Code: DZE
• UDI-Device Identifier: 00893202000028
• UDI-Public: 00893202000028
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 02071-NB-SB
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Congenital Anomaly; Hospitalization
• Patient Sex: Unknown