MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION; HANDPIECE, CONTRA- AND RIGHT- ANGLE ATTACHMENT, DENTAL

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

Patient presented to the oral oncology service for prosthetic rehabilitation.This patient had a hemimandibulectomy with fibula flap reconstruction in 2012.He was intraorally rehabilitated with a conventional interim removable prosthesis in enhancing chewing efficiency.In 2014, patient presented to the oral oncology service for rest seats prepared onto teeth for a definitive prosthesis.This requires a high speed handpiece and diamond bur (dental drill).During the procedure, while the handpiece was in the mouth, the head of the device disassembled at very high speed and the "chuck" component fell off and went down the patient's throat.Patient was not in an airway compromise; however, they had a sensation that something was lodged in the back of the throat.The fellow physician assessed the patient's mouth and throat and could not locate the chuck mechanism that held the diamond bur.The floor nurse manager contacted a triage nurse in the emergency center (ec) and escorted patient to the ec.The head and neck team was contacted, examined the patient in the ec, had a throat radiograph taken, and located the "chuck with bur" in the pyriform sinus and could not retrieve it with an instrument.Patient was taken to the operating room and had monitored anesthesia with easy retrieval of the "chuck and bur component." no damage was done to the oral or pharyngeal soft tissues.There was no bleeding.Patient was awakened with no harm to the head and neck and no functional deficits thereafter.

• Brand Name: MIDWEST TRADITION
• Type of Device: HANDPIECE, CONTRA- AND RIGHT- ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; * ; * *
• MDR Report Key: 4371597
• MDR Text Key: 5112046
• Report Number: 4371597
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2014
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 47 YR
• Patient Weight: 78