FDA Adverse Event Injury Summary report: N

DAMON CLEAR

MDR report key: 3473409 · Received November 18, 2013

Report

Report Number: 2016150-2013-00108
Event Type: Injury
Date Received: November 18, 2013
Report Date: October 17, 2013
Manufacturer: ORMCO CORPORATION
Product Code: NJM
PMA / PMN Number: K081415
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO OBJECTIVE EVIDENCE OF THE NUMBER OF PATIENTS INVOLVED WAS PROVIDED. SPECIFIC INFORMATION REGARDING PATIENT AGES, GENDERS, AND WEIGHTS WERE NOT PROVIDED BY THE DOCTOR. ALTHOUGH THE DOCTOR IDENTIFIED SIXTEEN (16) DIFFERENT DAMON CLEAR CATALOG NUMBERS ASSOCIATED WITH THE BROKEN BRACKET DOORS, HE COULD NOT VERIFY WHICH CATALOG NUMBER WAS USED ON ANY OF THE PATIENTS, AND NO LOT NUMBERS WERE PROVIDED FOR ANY OF THE ALLEGED PRODUCT; THEREFORE, NO CATALOG NUMBERS OR LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE CATALOG NUMBERS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE: 497-6463, 497-6462, 497-6473, 497-6472, 497-6461, 497-6460, 497-6471, 497-6470, 497-6481, 497-6491, 497-7491, 497-6421, 497-6420, 497-7481, 497-7780, AND 497-6480. THE DOCTOR REPORTED THAT HE REMOVED EACH OF THE PATIENTS' BRACKETS AND REPLACED THEM WITH A DIFFERENT PRODUCT. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICES, YIELDING INCONCLUSIVE RESULTS; THEREFORE, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE IDENTIFIED.

Description of Event or Problem · 1

A DOCTOR'S OFFICE ALLEGED THAT ALLEGED THAT DAMON CLEAR BRACKET DOORS HAD BROKEN AND HAD CAUSED UNANTICIPATED TOOTH MOVEMENTS DURING ORTHODONTIC TREATMENTS ON MULTIPLE PATIENTS. THIS IS THE FIRST OF FIVE (5) REPORTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
595638	DAMON CLEAR	CERAMIC ORTHODONTIC BRACKET	NJM	ORMCO CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R