MAUDE Adverse Event Report: DENTSPLY MAILLEFER CARBIDE BUR; BUR, DENTAL

Catalog Number E013734101000

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Per condition #1 of exemption e2006004, events meeting the definition of a serious injury are required to be reported.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused ur is available for evaluation.Nothing unusual to report was found during dhr review (batch #1589832).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 carbide bur broke during use which caused the patient's gums to tear and have bleeding points.All the broken parts have been retrieved from patient's mouth.

• Brand Name: CARBIDE BUR
• Type of Device: BUR, DENTAL
• 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: 11168174
• MDR Text Key: 226787934
• Report Number: 8031010-2020-00283
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E013734101000
• Device Lot Number: 1589832
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention