MAUDE Adverse Event Report: COLTENE/WHALEDENT AG DIATECH DIAMOND INSTRUMENTS; DIAMOND DENTAL BUR

Model Number 210857DD

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  Injury  

Event Description

An issue with a dental burr that occurred in the dental clinic at (b)(6) hospital.A flame-d862-012-8.0/ml was used in a procedure, and a tip broke off and was swallowed.No reported injury but the patient was hospitalized.Patient was subsequently discharged with no other known negative impact at this time.Hospital wrote at (b)(6) 2022: "unfortunately, we are unable to provide additional information at this time.".

Manufacturer Narrative

See attachment.

• Brand Name: DIATECH DIAMOND INSTRUMENTS
• Type of Device: DIAMOND DENTAL BUR
• Manufacturer (Section D): COLTENE/WHALEDENT AG; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• Manufacturer (Section G): COLTENE/WHALEDENT AG; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• Manufacturer Contact: roland streuf ; feldwiesenstrasse 20; altstätten, ch-9450 ; SZ
• MDR Report Key: 15184319
• MDR Text Key: 297488076
• Report Number: 9613375-2022-00001
• Device Sequence Number: 1
• Product Code: DZP
• UDI-Device Identifier: J006210857DD0
• UDI-Public: J006210857DD0
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 210857DD
• Device Catalogue Number: D862-012-8.0/ML
• Device Lot Number: L15788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization