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

Catalog Number	HT2.5LG
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the purple and green stripes on a hex wrench implant driver were noted to be removed after autoclaving the instrument.There was no patient involvement.

• Brand Name: SIMPLYLEGACY DRIVER
• Common Device Name: DENTAL IMPLANT DRIVER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8621983
• Report Number: 3001617766-2019-00229
• Device Sequence Number: 254751
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2023
• Device Catalogue Number: HT2.5LG
• Device Lot Number: 117316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1