MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART IQ BASIC STARTER KIT; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number A105400000000

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

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

Event Type  malfunction  

Event Description

In this event it is reported that x-smart iq basic starter kit won't hold files.No injury occurred.

Manufacturer Narrative

There has been a previous report received with 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 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Inspection found: following agreement with the after sales service, dentsply sirona thailand will not return the product.A credit note will be issued for the spare parts replaced by the repair center.Credit note issued for 1x iq contra-angle a105100000000.Sav various mechanical problem.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: X-SMART IQ BASIC STARTER KIT
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 14842436
• MDR Text Key: 303256694
• Report Number: 8031010-2022-00587
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A105400000000
• Device Lot Number: 1556917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/15/2022
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1