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

Model Number	31806-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Locator-fracture.

• Brand Name: LOCATOR ABUTMENT
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• MDR Report Key: 8941654
• Report Number: 2023950-2019-00469
• Device Sequence Number: 2151446
• Product Code: NHA
• UDI-Device Identifier: 00840481121449
• UDI-Public: 00840481121449
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 31806-05
• Device Catalogue Number: N/A
• Device Lot Number: I20MZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/28/2019
• 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