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

Model Number	07465-S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
Non-integration noted.The implants were inserted according to the lodis instructions for use and screwed in with a dehmoment of 30ncm.Thus good osseostability.A month later, the patient came with the spontaneously explanted implants.
Event or Problem Description
Non-integration noted.The implants were inserted according to the lodis instructions for use and screwed in with a dehmoment of 30ncm.Thus good osseostability.A month later, the patient came with the spontaneously explanted implants.

• Brand Name: IMPLANT, ENDOSSEOUS
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave, east; carlsbad CA 92010
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave, east; carlsbad
• Manufacturer Contact: amie toor ; 2875 loker ave, east; carlsbad, CA 92010
• MDR Report Key: 25117351
• Report Number: 2023950-2026-00045
• Device Sequence Number: 10339012
• Product Code: DZE
• UDI-Device Identifier: 00840481101571
• UDI-Public: 00840481101571
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 07465-S
• Device Catalogue Number: N/A
• Device Lot Number: L3CX9
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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: Other
• Patient Sex: Unknown