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

Model Number	07512-S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Non- integration.I have a doctor who ran into an issue while placing one of our implants.As he was inserting the last implant, it felt tight, so he backed out and attempted to reinsert it.As he was torquing it down with his motorized handpiece, he realized it was no longer engaging with the carrier.He then tried torquing manually and with the driver, but the implant still wasn't engaging with the internal hex.The implant isn't fully seated at the crest, and he removed it.
Event or Problem Description
Non- integration.I have a doctor who ran into an issue while placing one of our implants.As he was inserting the last implant, it felt tight, so he backed out and attempted to reinsert it.As he was torquing it down with his motorized handpiece, he realized it was no longer engaging with the carrier.He then tried torquing manually and with the driver, but the implant still wasn't engaging with the internal hex.The implant isn't fully seated at the crest, and he removed it.

• Brand Name: IMPLANT, ENDOSSEOUS
• 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: 23872861
• Report Number: 2023950-2025-00218
• Device Sequence Number: 17256035
• Product Code: DZE
• UDI-Device Identifier: 00840481131356
• UDI-Public: 00840481131356
• 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: 2025
• Device Explanted Year: 2025
• 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): 01/16/2026

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: 07512-S
• Device Catalogue Number: N/A
• Device Lot Number: L3GKR
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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