MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROPEX PIXI APEX LOCATOR; LOCATOR, ROOT APEX

Catalog Number A103000000100

Device Problem Incorrect Measurement (1383)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated and found to be within specification.Multiple unsuccessful attempts were made to obtain the patient outcome.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 dentsply (b)(4).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 propex pixi apex locator was giving incorrect measurements.The event outcome is unknown as of this mdr evaluation.

• Brand Name: PROPEX PIXI APEX LOCATOR
• Type of Device: LOCATOR, ROOT APEX
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): FORUM ENGINEERING TECHNOLOGIES (96) LTD.; 1 platin str.; new industrial zone; rishon lezion hamerkaz, 75653 39; IS 7565339
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 10486323
• MDR Text Key: 220979215
• Report Number: 8031010-2020-00076
• Device Sequence Number: 1
• Product Code: LQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A103000000100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1