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

Catalog Number	HT1.25
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), during clinical procedure, the driver got fractured.

• Brand Name: HEX TOOL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9449797
• Report Number: 3001617766-2019-05634
• Device Sequence Number: 3040395
• Product Code: NDP
• UDI-Device Identifier: 10841307119609
• UDI-Public: 10841307119609
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: HT1.25
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention