X-SMART PLUS
Report
- Report Number
- 8031010-2021-00396
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- December 1, 2021
- Report Date
- June 9, 2022
- Manufacturer
- MAILLEFER INSTRUMENTS HOLDING SARL
- Product Code
- EGS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.
DEVICE FOR THIS COMPLAINT WAS RECEIVED AND AFTER INSPECTION/INVESTIGATION FOUND RECEIVED = 1X X-SMART PLUS BEARING RETAINER H1033C1051113. 1X X-SMART PLUS CARTRIDGE H1033C1051015. 1X X-SMART PLUS DRIVE SHAFT H1033C1051022. 1X X-SMART PLUS HEAD CAP H1033C1051050. 1X X-SMART PLUS WAVE WASHER H1033C427A360. X-SMART PLUS CARTRIDGE. VARIOUS MECHANICAL PROBLEM. INSIDE THE CARTRIDGE MOVES (WHEN A FILE IS FIXED).
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.
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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
N THIS EVENT IT WAS REPORTED THAT AN X-SMART PLUS CONTRA ANGLE WON'T HOLD FILES; NO INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1904563 | X-SMART PLUS | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | EGS | MAILLEFER INSTRUMENTS HOLDING SARL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |