FDA Adverse Event
Injury
Summary report: N
IMPLANTMED SI-915, 2011
MDR report key: 7845143
·
Received September 5, 2018
Report
- Report Number
- 9681479-2018-00006
- Event Type
- Injury
- Date Received
- September 5, 2018
- Date of Event
- August 22, 2018
- Report Date
- August 28, 2018
- Manufacturer
- W&H DENTALWERK BUERMOOS GMBH
- Product Code
- EBW
- PMA / PMN Number
- K052741
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AFTER ANALYSING THE PRODUCT, THERE WAS NO PROBLEM FOUND. THE ANALYSIS SHOWED IT WAS NORMAL WEAR AND TEAR.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688208 | IMPLANTMED SI-915, 2011 | DENTAL DRILL UNIT | EBW | W&H DENTALWERK BUERMOOS GMBH | 06631600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |