MAUDE Adverse Event Report: DENTSPLY MAILLEFER SPREADER A; SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Catalog Number A019802500000

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

However, since there has been a previous report received with the same product where this malfunction resulted in a serious injury 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.Involved spreader a025 that broke was not returned and cannot be analyzed.Moreover, no unused instrument is available for evaluation.Right batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.

Event Description

In this event it was reported that a spreader broke in the teacher's hands during a demonstration.No injured resulted.

• Brand Name: SPREADER A
• Type of Device: SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 10909759
• MDR Text Key: 219159759
• Report Number: 8031010-2020-00245
• Device Sequence Number: 1
• Product Code: EKK
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/25/2020

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: A019802500000
• Device Lot Number: 1573570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1