MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL

Model Number HT1.25

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), during the clinical procedure, the doctor could not remove the impression post and stripped 3 drivers.Per the complaint, the doctor states that he did not use a torque wrench to tighten screw but when he tried to remove the screw from the implant it was stuck.He has stripped or broken multiple tips and tried the ultra sonic to try to break up anything wedging the abutment in place, nothing worked.Additionally, the doctor has applied to up to 60 ncm of counterclockwise torque and the screw wouldn't move.The implant was extracted.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.Information for section a1, a2, a3, a4 were not available.When information becomes available, a supplemental report will be filed.

• Brand Name: HEX TOOL
• Type of Device: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8765249
• MDR Text Key: 150310773
• Report Number: 3001617766-2019-00298
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119609
• UDI-Public: 10841307119609
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/22/2020

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 Model Number: HT1.25
• Device Catalogue Number: HT1.25
• Device Lot Number: 123139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention