MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC OFF-AXIS DRIVER ACCESS PLUG; DENTAL IMPLANT

Catalog Number DAP

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per complaint (b)(4), the udi number on the product label was incorrect.This is an internal complaint, there was no patient involvement.

• Brand Name: OFF-AXIS DRIVER ACCESS PLUG
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 9800302
• MDR Text Key: 182407161
• Report Number: 3001617766-2020-01905
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307122968
• UDI-Public: 10841307122968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Catalogue Number: DAP
• Device Lot Number: 86493
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention