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

Catalog Number HT2.0LG

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 02/25/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), a driver tool broke inside a dental implant during initial placement.The broken piece was unable to be removed.The implant was removed and replaced within the same procedure.No adverse patient consequences were reported.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: SIMPLYLEGACY HEX WRENCH IMPLANT DRIVER
• Type of Device: DENTAL IMPLANT DRIVER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8597659
• MDR Text Key: 144707235
• Report Number: 3001617766-2019-00217
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119814
• UDI-Public: 10841307119814
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT2.0LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR