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

Model Number	08631
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that locator abutment fractured at the threads of the abutment.Doctor tried to remove the fractured portion but it was not possible.Implant was removed and a new implant was placed.Implant reference: (b)(4).Implant lot: 2022040382.
Event or Problem Description
It was reported that locator abutment fractured at the threads of the abutment.Doctor tried to remove the fractured portion but it was not possible.Implant was removed and a new implant was placed.Implant reference: (b)(4).Implant lot: 2022040382.

• 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 east; carlsbad 92010 ; 7608712036
• MDR Report Key: 16211118
• Report Number: 2023950-2022-00541
• Device Sequence Number: 20197430
• Product Code: DZE
• UDI-Device Identifier: 00893202000820
• UDI-Public: 00893202000820
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 08631
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown