FDA Adverse Event
Malfunction
Summary report: N
X-SMART
MDR report key: 2082130
·
Received April 27, 2011
Report
- Report Number
- 8031010-2011-00036
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Report Date
- March 28, 2011
- Manufacturer
- DENTSPLY MAILLEFER
- Product Code
- LQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING THIS MALFUNCTION THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS RETURNED, EVALUATED, AND FOUND TO HAVE A SHORT CIRCUIT IN THE MOTOR CONNECTOR.
Description of Event or Problem · 1
IN THIS EVENT, IT WAS REPORTED THAT A X-SMART DUAL APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; EVENT OUTCOME IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-SMART | LQY | DENTSPLY MAILLEFER | 8527U0906R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |