MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ CONTRA ANGLE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number XSIQCA

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, 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.Received - 1x x-smart iq ca apex contact h105107089000.1x x-smart iq ca head gear assy h105105872900.1x x-smart iq ca middle gear assy h105107065500.X-smart iq ca head gear assy.Various mechanical problem.Rusty.X-smart iq ca middle gear assy.Various mechanical problem.Rusty.X-smart iq ca apex contact.Defect.Replaced 1 x iq ca apex contact h105107089000, 1 x iq ca head gear assy h105105872900 and 1 x iq ca middle gear assy h105107065500.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

In this event it was reported that a x-smart iq , used in combination with a propex iq apex locator ,was giving incorrect measurements.

• Brand Name: X-SMART IQ CONTRA ANGLE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11256460
• MDR Text Key: 231789779
• Report Number: 8031010-2020-00086
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XSIQCA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1