MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART PLUS; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number A103200000000

Device Problem Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.This event will be reevaluated, as appropriate, if additional information becomes available.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by (b)(4).Evalaution found a faulty reduction shank.Multiple unsuccessful attempts were made to obtain the patient outcome.

Event Description

In this event it was reported that a xsmart plus suddenly went into auto reverse mode.The event outcome is unknown as of this mdr evaluation.However, there is no indication that injury resulted.

Manufacturer Narrative

Additional information was received indicating that no patient was injured.

• Brand Name: X-SMART PLUS
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 7366877
• MDR Text Key: 103557244
• Report Number: 8031010-2018-00039
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A103200000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Patient Sequence Number: 1