MAUDE Adverse Event Report: SYBRONENDO ELEMENTS OBTURATION UNIT; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number 973-0322

Device Problem Detachment Of Device Component (1104)

Patient Problem Burn(s) (1757)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

Patient information with regard to sex, age, and weight was not provided.The minor burn on the patient's face did not require medication.Iodophor was applied to the tongue of the patient.The patient fully recovered after two (2) days.A device evaluation is anticipated but has not yet begun.

Event Description

A doctor alleged that a component of the elements obturation unit detached from the extruder twice during a patient's procedure, causing burns on the patient's face and tongue.

• Brand Name: ELEMENTS OBTURATION UNIT
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: mark dzendzel ; 1717 w collins ave; orange, CA 92867 ; 7145167802
• MDR Report Key: 5267836
• MDR Text Key: 32703461
• Report Number: 2016150-2015-00023
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 973-0322
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other; Required Intervention