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

Model Number	08403-SB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The locator broke when placed in implant.Implant had to removed and placed a new one at site #3.
Event or Problem Description
The locator broke when placed in implant.Implant had to removed and placed a new one at site #3.

• 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: 17765683
• Report Number: 2023950-2023-00285
• Device Sequence Number: 6976081
• Product Code: NHA
• UDI-Device Identifier: 00840481116971
• UDI-Public: 00840481116971
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 08403-SB
• Device Catalogue Number: N/A
• Device Lot Number: L2AYF
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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