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

Model Number HT2.5LG

Device Problem Positioning Problem (3009)

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

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), driver got stuck in implant and could not removed from implant.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated b7 for other relevent history to include ni for no information available.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d10 for device return date, g1-g2 for follow-up report submitter, g4 for awareness date g5 for pma/510(k) and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Updated d4 for lot # to include ni for no information available.Section d4 for expiration date, h4, no information was available.This report is submitted late and is captured within capa(b)(4).

• Brand Name: SIMPLYLEGACY DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9190237
• MDR Text Key: 167335001
• Report Number: 3001617766-2019-04650
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

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 Model Number: HT2.5LG
• Device Catalogue Number: HT2.5LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR