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

Catalog Number HT2.5

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/20/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), it was reported that a dental implant driver was jammed into a dental implant during initial placement.On the same day, the implant was removed with the driver still attached to it.Pain was reported.

• Brand Name: HEX TOOL
• Type of Device: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8629822
• MDR Text Key: 145753055
• Report Number: 3001617766-2019-00232
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307102045
• UDI-Public: 10841307102045
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2023
• Device Catalogue Number: HT2.5
• Device Lot Number: 109591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR