MAUDE Adverse Event Report: DENTSPLY MAILLEFER POST SPACE BUR; DENTAL BUR

Catalog Number A005131900500

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 01/18/2014

Event Type  Injury  

Event Description

In this event it was reported that a post space bur twisted during treatment and caused an injury to a patient that required two stitches.The patient recovered without sequela.

Manufacturer Narrative

Preliminary investigation shows that the post space bur meets specifications (hardness).Therefore, because an injury occurred, this event meets the criteria for reportability per 21 cfr part 803.Three post space burs 31mm 005 have been received and are actually damaged (strongly bent at the base of the active part).The batch number is unknown, dhr cannot be reviewed.Despite the fact that the instruments are damaged, our laboratory team was able to take some measures on two returned burs and shows that the active parts diameters are within specifications.Moreover, the instruments have the required hardness.Some measurements and tests were conducted on similar product available in our inventory.The burs were found in compliance with drawing specifications and were tested according to the recommendations (20 samples).Following this test, none of the bur had undergone the slightest permanent deformation.Root causes are not identified.Please note that this product is not sold in the u.S., it is considered similar to products that are when taking into account composition and indications for use.

• Brand Name: POST SPACE BUR
• Type of Device: DENTAL BUR
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 3690546
• MDR Text Key: 4254907
• Report Number: 8031010-2014-00001
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A005131900500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONTRA ANGLE
• Patient Outcome(s): Required Intervention