MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARBIDE BUR CAVITY ROUND FG012; BUR, DENTAL

Catalog Number E012334101200

Device Problem Sharp Edges (4013)

Patient Problems Abrasion (1689); Tissue Breakdown (2681)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are: involved product that didn't give satisfaction was not returned and cannot be analyzed.Moreover, no unused bur is available for evaluation.Nothing unusual to report was found during dhr review (batch #1767088).Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Event Description

In this event it is reported that carbide bur cavity round fg012 that was used during treatment reportedly the surface of the bur was not smooth.After treatment gingival bleeding was found.Hemostasis by compression was used to stop the bleeding.Further information requested.

• Brand Name: CARBIDE BUR CAVITY ROUND FG012
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18130809
• MDR Text Key: 328041144
• Report Number: 8031010-2023-00867
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: J003E0123341012001
• UDI-Public: J003E0123341012001
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: E012334101200
• Device Lot Number: 1767088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/06/2023
• Date Manufacturer Received: 11/06/2023
• Type of Device Usage: A
• Patient Sequence Number: 1