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

Model Number	07457
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported bone expansion done, no drilling.Additional corticocancellous bone added.Implant removed due to failure to integrate with infection present.No patient history to report and moderate bone type.Implant site was grafted previously or simultaneously with allograft.Implant was not and immediate placement and was done in two stages.Implant was not load/restored prior to failure.Xray provided is for site 24-25.
Event or Problem Description
It was reported bone expansion done, no drilling.Additional corticocancellous bone added.Implant removed due to failure to integrate with infection present.No patient history to report and moderate bone type.Implant site was grafted previously or simultaneously with allograft.Implant was not and immediate placement and was done in two stages.Implant was not load/restored prior to failure.Xray provided is for site 24-25.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad,
• MDR Report Key: 9930471
• Report Number: 2023950-2020-00145
• Device Sequence Number: 14062853
• Product Code: DZE
• UDI-Device Identifier: 00840481101533
• UDI-Public: 00840481101533
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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
• Operator of Device: No Information
• Device Model Number: 07457
• Device Catalogue Number: N/A
• Device Lot Number: L0EGY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention