MAUDE Adverse Event Report: DENTSPLY MAILLEFER CARBIDE BUR CAV.CYL.SQUARE FG 010; BUR, DENTAL

Catalog Number E013734101000

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Per condition #1 of exemption (b)(4), events meeting the definition of a serious injury are required to be reported.Therefore, because of the patient bled, this event meets the criteria for reportability per 21 cfr part 803.Involved carbide bur cav.Cyl.Square fg 010 that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1426885).Root causes are not identified.This kind of event is tracked and we monitor the trend.

Event Description

In this event it was reported that a carbide bur cavity broke during use while a tooth extraction was performed.During this act, the buccal oral mucosa was scratched about 2 mm long.After pressing with dry cotton ball for 2 minutes, the mucosa was not bleeding anymore.

• Brand Name: CARBIDE BUR CAV.CYL.SQUARE FG 010
• 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: 8966912
• MDR Text Key: 161198003
• Report Number: 8031010-2019-00175
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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: 1426885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention