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

Model Number	07461-S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Non integration.Patient walked into the office with the implant in their hand, his body rejected the implant, and there was no integration.
Event or Problem Description
Non-integration.Patient walked into the office with the implant in their hand, his body rejected the implant, and there was no integration.
Additional Manufacturer Narrative
N/a.

• 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: 50047734
• Report Number: 2023950-2026-00074
• Device Sequence Number: 10636336
• Product Code: DZE
• UDI-Device Identifier: 00840481101557
• UDI-Public: 00840481101557
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 07461-S
• Device Catalogue Number: N/A
• Device Lot Number: L2VU1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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