FDA.reportPublic FDA data

MAUDE MDR 1398205

MDR report key
1398205
Report number
2016150-2009-00036
Event key
0
Event type
3
Date of event
2009-05-06
Date received
2009-06-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. ORLANDO TADEO, JR.
Address
1717 W COLLINS AVE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DAMON DEBONDING PLIERSORTHODONTIC PLIERORMCO CORPORATIONJEX866-400807F51FY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-0401. O; 2. R

Event Narratives#

D

Patient 1

IN 2009, ORMCO CORPORATION RECEIVED NOTIFICATION THAT DURING THE DEBONDING OF BRACKETS, THE TIP OF THE DAMON DEBONDING PLIER BROKE AND FRACTURED THE CROWN PORTION OF A PATIENT'S TOOTH #41.

N

Patient 1

THE DOCTOR REPORTED THAT THE PATIENT WAS SENT TO HIS DENTIST IMMEDIATELY AFTER THE INCIDENT TO HAVE THE FRACTURED TOOTH EXAMINED. THE PATIENT'S DENTIST REMOVED THE FRACTURED TOOTH PORTION, PERFORMED A ROOT CANAL AND PLACED A TEMPORARY CROWN. THE PATIENT IS CURRENTLY DOING WELL AND WAITING FOR THE PLACEMENT OF A PERMANENT CROWN. THE DOCTOR REPORTED THAT AN EVALUATION OF THE PATIENT'S X-RAYS INDICATED THAT THERE WAS NO DAMAGE TO THE PATIENT'S TOOTH STRUCTURE PRIOR TO ORTHODONTIC TREATMENT. THE DOCTOR HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL PATIENT DENTAL HISTORY INFORMATION FROM THE PATIENT'S DENTIST; HOWEVER, THE PATIENT'S DENTIST HAS REMAINED UNRESPONSIVE. THE PRODUCT WAS RETURNED TO ORMCO CORPORATION FOR EVALUATION. THE EVALUATION WAS UNABLE TO DETERMINE THE CAUSE OF THE TIP BREAKAGE. THE RESULTS OF MATERIAL HARDNESS TESTING INDICATED THAT THE TIP WAS WITHIN PRODUCT SPECIFICATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED RUST ON THE TIP AND TWO PITS WHICH INDICATE WHERE THE FRACTURE ORIGINATED. IT CANNOT BE OPTICALLY DETERMINED HOWEVER, IF THESE PITS EXISTED PRIOR TO THE BREAKAGE OR IF THEY OCCURRED AS A RESULT OF THE BREAKAGE.THIS IS THE FINAL REPORT. - ATTACHMENT: [DAMONDEBONDINGPLIER 2016150-2009-00036 - EVALUATION.PDF]