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

Catalog Number HD1.25

Device Problems Break (1069); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 04/23/2019

Event Type  Injury  

Event 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
• Type of Device: HEX DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8761131
• MDR Text Key: 150120375
• Report Number: 3001617766-2019-00294
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119548
• UDI-Public: 10841307119548
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: HD1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR