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

Model Number	08972-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 screw in implant broken, defective locator attached.The implant is still in the patient according to fr.Faibt, is still intact.
Event or Problem Description
Locator screw in implant broken, defective locator attached.The implant is still in the patient according to (b)(6), is still in tact.

• 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: 18319191
• Report Number: 2023950-2023-00390
• Device Sequence Number: 7316543
• Product Code: DZE
• UDI-Device Identifier: 00840481116728
• UDI-Public: 00840481116728
• 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 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): 01/05/2023

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: 08972-SB
• Device Catalogue Number: N/A
• Device Lot Number: L2JZ1
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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: Required Intervention; Congenital Anomaly
• Patient Sex: Unknown