FDA Adverse Event
Malfunction
Summary report: N
VDW GOLD/SILVER CONTRA ANGLE
MDR report key: 11073346
·
Received December 24, 2020
Report
- Report Number
- 9611053-2020-00394
- Event Type
- Malfunction
- Date Received
- December 24, 2020
- Report Date
- January 31, 2021
- Manufacturer
- DENTSPLY VDW GMBH
- Product Code
- EGS
- PMA / PMN Number
- NA#S-P#NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
CONTRA ANGLE 141806 (2019) (BEARING) DEFECTIVE.
Additional Manufacturer Narrative · 1
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT A CONTRA ANGLE 6:1 FOR VDW.GOLD/SILVER WOULD NOT HOLD FILES; NO INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1535306 | VDW GOLD/SILVER CONTRA ANGLE | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | EGS | DENTSPLY VDW GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |