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

Catalog Number 854210U

Device Problem Compatibility Problem (2960)

Patient Problem Failure of Implant (1924)

Event Date 07/27/2018

Event Type  malfunction  

Event Description

Per complaint (b)(4), when placing the implant, the insertion tool became stuck within the implant.It was removed using needle nose pliers.

• Brand Name: SIMPLY LEGACY 3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks 91362 ; 8184443300
• MDR Report Key: 7831165
• MDR Text Key: 118749147
• Report Number: 3001617766-2018-00209
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307107804
• UDI-Public: 10841307107804
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Catalogue Number: 854210U
• Device Lot Number: 107654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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 Age: 64 YR