MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HT2.3; HEX TOOL

Catalog Number	HT2.3
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4) , a hex tool key got stuck to a dental implant during initial placement.The implant was removed and replaced with a wider implant on the same day.No adverse patient consequences were reported.

• Brand Name: HT2.3
• Common Device Name: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8558726
• Report Number: 3001617766-2019-00197
• Device Sequence Number: 11572122
• Product Code: NDP
• UDI-Device Identifier: 10841307119623
• UDI-Public: 10841307119623
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: HT2.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR