MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; DENTAL IMPLANT

Model Number HT3.0LG

Device Problem Defective Component (2292)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), during clinical procedure, 3.0 driver welded into the platform of implant.Implant was removed and driver was still stuck.

• Brand Name: SIMPLYLEGACY DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 9710746
• MDR Text Key: 179412014
• Report Number: 3001617766-2020-01602
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119890
• UDI-Public: 10841307119890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/14/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: HT3.0LG
• Device Catalogue Number: HT3.0LG
• Device Lot Number: 90792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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: 66 YR