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

Catalog Number E015134100000

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Per condition #1 of (b)(4), events meeting the definition of a serious injury are required to be reported.Therefore, because of the separated piece was removed surgically, this event meets the criteria for reportability per 21 cfr part 803.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 a carb.B.Surgery zekrya separated during first use inside the bone; the customer had to perform surgery to remove the broken piece.

Manufacturer Narrative

Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused bur is available for evaluation.The provided batch number (#1463637) has no corresponding with the catalog # involved in this complaint.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: ZEKRYA BUR
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 8340475
• MDR Text Key: 136232183
• Report Number: 8031010-2019-00005
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E015134100000
• Device Lot Number: 1438586
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention