MAUDE Adverse Event Report: STAR DENTAL HI SPEED HAND PIECE

Model Number 430 SW

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/02/2018

Event Type  Injury  

Event Description

During the crown prep procedure, a diamond bur used to remove the patient's existing crown separated from the handpiece.The bur did not break, but completely dislodged from the handpiece (the handpiece has since been sent to be fixed).Attempt was made to suction the bur at the back of the patient's mouth, but the patient's gag reflex made the patient swallow or aspirate bur.

• Brand Name: HI SPEED HAND PIECE
• Type of Device: HI SPEED HAND PIECE
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 7478914
• MDR Text Key: 107251372
• Report Number: MW5076959
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 430 SW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR