MAUDE Adverse Event Report: STAR DENTAL STAR DENTAL; HIGH SPEED HANDPIECE

Model Number 430 SW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2017

Event Type  malfunction  

Event Description

During a crown prep procedure, a bur flew out of the handpiece during the procedure and the pt swallowed the bur.

• Brand Name: STAR DENTAL
• Type of Device: HIGH SPEED HANDPIECE
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 6800126
• MDR Text Key: 83096507
• Report Number: MW5071610
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430 SW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• 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: 51 YR