MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN; CARBIDE BUR SURGICAL BONE FG 541A

Catalog Number	102-2417
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
While a 35 year old male patient was having a dental surgical extraction procedure the patient heard the noise of the drill and felt the vibration and clamped down on the handpiece closing his mouth.This motion dislodged the bur out of the handpiece.The patient began to cough making it difficult to capture the bur with both high speed suctions in the mouth of the patient.The patient was instructed to sit up and cough however the bur was not recovered.The patient was in good condition.The patient was given a referral for a chest radiograph and instructed to go as soon as possible for locating the bur.As of the date of this report, the reporter stated the patient has not gone to get an x-ray.

• Brand Name: HENRY SCHEIN
• Common Device Name: CARBIDE BUR SURGICAL BONE FG 541A
• Manufacturer (Section D): PRIMA DENTAL GROUP; stephenson drive waterwells; business park, gloucester, GL2 2 HA; UK GL2 2HA
• MDR Report Key: 18839754
• Report Number: 2411236-2024-00002
• Device Sequence Number: 17961955
• Product Code: EJL
• UDI-Device Identifier: 10304040071509
• UDI-Public: (01)10304040071509(11)2024/01/05(10)1532250
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/05/2024
• Report Date (Section F): 03/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 102-2417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2024
• Event Location: Other
• Date Report to Manufacturer: 03/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/05/2024