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

Catalog Number	HD1.25
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), a hex tool broke within a dental implant during the implant procedure.The tool was stuck within the top part of the implant.The patient's bone was drilled as a consequence.

• Brand Name: HEX DRILL
• Common Device Name: HEX DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8761131
• Report Number: 3001617766-2019-00294
• Device Sequence Number: 1591294
• Product Code: NDP
• UDI-Device Identifier: 10841307119548
• UDI-Public: 10841307119548
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HD1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/03/2019
• 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
• Patient Age: 70 YR