FDA.reportPublic FDA data

MAUDE MDR 7543397

MDR report key
7543397
Report number
2016150-2018-00019
Event key
0
Event type
3
Date received
2018-05-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PAULO CALLE
Address
1717 W COLLINS AVENUE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYBRONENDOELEMENTS OBTURATION UNIT,SYBRONENDOEKZ973-0322R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-240

Event Narratives#

N

Patient 1

SPECIFIC INFORMATION WITH REGARD TO THE EXACT NUMBER OF PATIENTS AFFECTED, GENDERS, AGES, AND WEIGHTS WAS NOT PROVIDED. THE DATE OF EVENT WAS NOT PROVIDED. DEVICE MANUFACTURE DATE IS PENDING. THE DOCTOR REPORTED THAT WHEN ROOT CANALS FAILED EXTRACTIONS HAD TO BE DONE AND IMPLANTS INSERTED. THE PRODUCT HAS BEEN IDENTIFIED AS AN AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.

D

Patient 1

A DOCTOR ALLEGED THAT THERE WERE CASES WERE POSTOPERATIVE SENSITIVITY AND ROOT CANAL FAILURE HAD OCCURED WHEN USING THE ELEMENTS OBTURATION UNIT WITH BUCHANAN TIPS.