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

Model Number	04321-2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the locator fracture at the screw portion and it was removed.Symptoms as a result of the event: abscess.

• 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
• MDR Report Key: 10833291
• Report Number: 2023950-2020-00434
• Device Sequence Number: 14334163
• Product Code: NHA
• UDI-Device Identifier: 00840481108877
• UDI-Public: 00840481108877
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 04321-2
• Device Catalogue Number: N/A
• Device Lot Number: L0RHK
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/12/2020
• 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: Hospitalization; Required Intervention