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

Catalog Number S206100254000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Injury (2348)

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 medical intervention was necessary to preclude permanent damage in this event, it does meet the criteria for reportability per 21 cfr part 803.This report is for the third dog.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that five carbide burs separated in five different dogs and the tooth was extracted in each of the five events.

Manufacturer Narrative

Only unused product has been received from the customer.Involved product that broke during use is not available and cannot be analyzed.Nothing unusual to report was found during dhr review.Unused product has been evaluated according to iso norms and meets expectations.Root causes are not identified.We will track this kind of event and monitor the trend.

• 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: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5524197
• MDR Text Key: 41134220
• Report Number: 8031010-2016-00020
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: S206100254000
• Device Lot Number: 1259758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability