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

Model Number	01940
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Account reported that customer complained about an allergy to the abutments.
Event or Problem Description
Account reported that customer complained about an allergy to the abutments.Zest evaluation: there is no product experience reported as for allergic reactions caused by the use of zest abutments.The zest abutment product does not contain nickel; therefore, the patient could not have an allergic reaction from the abutments.No physical evaluation can be performed as product was not returned.Zest was unable to find evidence of a manufacturing issue per current records, and believes that the components do not present any manufacturer errors.

• 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: 11942622
• Report Number: 2023950-2021-00216
• Device Sequence Number: 1152836
• Product Code: DZE
• UDI-Device Identifier: 00840481100277
• UDI-Public: 00840481100277
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 01940
• Device Catalogue Number: N/A
• Device Lot Number: L11LR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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