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

Model Number 07455-S

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  Injury  

Event Description

Fractur of locator 1.The fragments could not be removed, therefore explantation of 1 astra osseospeed ev 4.2 c-11 mm implant.

Event Description

Fractur of locator 1.The fragments could not be removed, therefore explantation of 1 astra osseospeed ev 4.2 c-11 mm implant.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Type of Device: 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 e; carlsbad
• MDR Report Key: 18895474
• MDR Text Key: 337563674
• Report Number: 2023950-2024-00089
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00840481101519
• UDI-Public: 00840481101519
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K120198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 07455-S
• Device Catalogue Number: N/A
• Device Lot Number: L0YE9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Congenital Anomaly