MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number A100400000000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a x-smartcontra angle did not hold files. The event outcome is unknown as of this mdr evaluation.

• Brand Name: X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12285458
• MDR Text Key: 267476999
• Report Number: 8031010-2021-00181
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• PMA/PMN Number: K990682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: A100400000000
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown