MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT

Catalog Number 853711

Device Problems Fracture (1260); Compatibility Problem (2960)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 06/07/2018

Event Type  Injury  

Event Description

Per complaint (b)(4), an implant failed to integrate and was removed.During the extraction the ixt tool became stuck within the implant and it was fractured.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated catalog and udi number, for device return date, for follow-up report submitter, for awareness date and for report type and follow-up number.Updated for follow-up type, for device evaluation status and method, result and conclusion codes.Device received is different from that which was submitted on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.

• Brand Name: LEGACY 3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8530364
• MDR Text Key: 142460538
• Report Number: 3001617766-2019-00173
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102052
• UDI-Public: 10841307102052
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/19/2023
• Device Catalogue Number: 853711
• Device Lot Number: 113343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR