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

Catalog Number A105410000000

Device Problems Detachment of Device or Device Component (2907); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received for a similar device 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 21 cfr part 803.

Event Description

In this event it was reported that a x-smart iq contra angle would not hold files; no injury resulted.

Manufacturer Narrative

X-smart iq handpiece.Various electronic problem.Multifunction button damaged.X-smart iq contra-angle: various mechanical problem.Noisy, not fluid rotation.Replaced 1 x iq handpiece h105900000000 sn (b)(6) and 1 x iq contra-angle a105100000000 sn (b)(6).

• Brand Name: X-SMART IQ CONTRA ANGLE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 12055739
• MDR Text Key: 260961509
• Report Number: 8031010-2021-00113
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: K161213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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 Catalogue Number: A105410000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1