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

Model Number HT2.5LG

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Event Description

Per complaint (b)(4), the ht2.5 tool became stuck in the implant.This resulted in the removal of the implant.

Manufacturer Narrative

No information was able to be obtainined for the following sections: a1, a4, d4 lot number and expiration date, and h5 - device manufacture date.Updated: b5, h5, h6: method, result and conclusion code.Correction: d4- cataloge and udi number, d6, d7, g5, h4, h5 previously reported implant date, explant date and device manufacture date do not apply.Additional information regarding the complaint was requested for verification, however no additional information is available as the clinician is no longer practicing.

Event Description

Per complaint 42443, during a dental implant clinical procedure a hex tool became stuck within the implant.The clinician first inserted the implant with the 2.5 tool, removed the tool and proceeded with ht2.0sg which became stuck within the implant.

• Brand Name: SIMPLYLEGACY DRIVER
• Type of Device: WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7801814
• MDR Text Key: 117833419
• Report Number: 3001617766-2018-00201
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT2.5LG
• Device Catalogue Number: HT2.0SG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR