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

Catalog Number HT2.0SG

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), a hex tool broke off within a dental implant during clinical procedure.The implant was also damaged.The implant was explanted.The procedure was completed within the same visit.No adverse patient consequences were reported.

• Brand Name: SIMPLYLEGACY DRIVER
• 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: 8834165
• MDR Text Key: 153953749
• Report Number: 3001617766-2019-00321
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307119821
• UDI-Public: 10841307119821
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/26/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: HT2.0SG
• Device Lot Number: 139082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1