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

Catalog Number	HT2.5
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), after a dental implant analog was removed, a hex tool was used to drive a dental implant into the patient's created socket.The hex tool got stuck to the implant, which caused the implant to loosen.Two forceps were used to separate the implant from the hex tool outside of the patient's mouth.A different implant was placed in the patient's mouth within the same day.No adverse patient consequences were reported.

• Brand Name: HEX TOOL
• Common Device Name: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8667462
• Report Number: 3001617766-2019-00250
• Device Sequence Number: 16721689
• Product Code: NDP
• UDI-Device Identifier: 10841307119630
• UDI-Public: 10841307119630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: HT2.5
• Device Lot Number: 47106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1