FDA Adverse Event Malfunction Summary report: N

X-SMART W/CONTRA ANGLE EUR

MDR report key: 13416356 · Received February 1, 2022

Report

Report Number: 8031010-2022-00432
Event Type: Malfunction
Date Received: February 1, 2022
Date of Event: January 17, 2022
Report Date: May 24, 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

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.

Additional Manufacturer Narrative · 0

DEVICE WAS RECEIVED AND INSPECTED. INSPECTION/INVESTIGATION RESULTS FOR THIS ARE: RECEIVED = 1X X-SMART CARTRIDGE H1004C5210150; 1X X-SMART HEAD CAP H1004C5210500; 1X X-SMART NECK H1004C5470220. X-SMART NECK: OTHER ROTATION NOT FLUID. REPLACED 1X X CARTRIDGE H1004C5210150; 1X X NECK H1004C5470220. 1X X HEAD CAP H1004C5210500

Description of Event or Problem · 0

IN THIS EVENT IT WAS REPORTED THAT AN X-SMART CONTRA ANGLE WON'T HOLD FILES; NO INJURY RESULTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2225261	X-SMART W/CONTRA ANGLE EUR	HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL	EGS	MAILLEFER INSTRUMENTS HOLDING SARL

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown