MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT

Catalog Number 804211

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

Patient's identifier and weight were not provided.When the requested information becomes available, a supplementary report will be submitted.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).

Event Description

Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.

• Brand Name: LEGACY 1 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10800024
• MDR Text Key: 215010923
• Report Number: 3001617766-2020-07805
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307100850
• UDI-Public: 10841307100850
• Combination Product (y/n): N
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Catalogue Number: 804211
• Device Lot Number: 119292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR