MAUDE Adverse Event Report: DENTSPLY MAILLEFER START-X EMS INSERT TIP; ULTRASONIC SCALER

Catalog Number A066100000300

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

In this event it was reported that a start x tip separated in a patient's mouth; the separated piece could not be retrieved and was incorporated into the filling.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21 cfr part 803.Please note that while this product is not sold in the u.S., it is considered similar to products that are when taking into account composition and indications for use.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

• Brand Name: START-X EMS INSERT TIP
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4418955
• MDR Text Key: 5165130
• Report Number: 8031010-2014-00011
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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
• Report Date: 12/09/2014

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: A066100000300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1