MAUDE Adverse Event Report: W&H IMPEX INC. SPARE MOTOR COMPLETE, IMPLANTMED SI-915, 2011, 1.8 M; DENTAL MOTOR

Catalog Number 06631600

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/28/2018

Event Type  Injury  

Event Description

It was reported that the motor (06631600) does not function.The handpiece drill did not turn when pressing down on the foot pedal of the motor.This error occurred during the procedure and the doctor was unable to complete it.The patient underwent anesthesia and a hole had been drilled in the mouth.The patient had to return on a different day to complete the procedure.

• Brand Name: SPARE MOTOR COMPLETE, IMPLANTMED SI-915, 2011, 1.8 M
• Type of Device: DENTAL MOTOR
• Manufacturer (Section D): W&H IMPEX INC.; 6490 hawthorne drive; windsor, on N8T 1 J9; CA N8T 1J9
• MDR Report Key: 7735425
• MDR Text Key: 115563396
• Report Number: 0001038806-2018-00713
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06631600
• Device Lot Number: 25481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2018
• Event Location: Other
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention