MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH IMPLANTMED SI-915, 2011; DENTAL DRILL UNIT

Catalog Number 16929001

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

After analysing the product, there was no problem found.The analysis showed it was normal wear and tear.

Event Description

It was reported that the drilling unit ((b)(4)) is overheating, won't turn, and won't spray water.The procedure was unable to be competed as the doctor was with a patient in the middle of treatment and the device malfunctioned.The patient will have to return.

• Brand Name: IMPLANTMED SI-915, 2011
• Type of Device: DENTAL DRILL UNIT
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: anja lindner ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 7845143
• MDR Text Key: 119151202
• Report Number: 9681479-2018-00006
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K052741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 16929001
• Device Lot Number: 06631600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other