FDA.reportPublic FDA data

MAUDE MDR 6687894

MDR report key
6687894
Report number
2320721-2017-00042
Event key
0
Event type
3
Date of event
2017-06-05
Date received
2017-07-05
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
MRS. HELEN LEWIS
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROTAPER UNIVERSAL OBTURATORSGUTTA-PERCHADENTSPLY TULSA DENTAL SPECIALTIESEKMNAPTUOB30F10000074463R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-050

Event Narratives#

N

Patient 1

THERE HAS BEEN A PREVIOUS REPORT RECEIVED 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 WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

D

Patient 1

A DOCTOR REPORTED THAT HE HAD OVERFILLED A PATIENT'S ROOT CANAL WITH A PROTAPER UNIVERSAL OBTURATOR. THE OBTURATOR EXITED THROUGH A PERFORATION CAUSED BY INTERNAL RESORPTION. THE DOCTOR REALIZED THIS AND RETRACTED THE OBTURATOR, BUT THE PIECE BEYOND THE PERFORATION STAYED. THE DOCTOR THEN TRIED TO SURGICALLY RETRIEVE THE PIECE WITHOUT SUCCESS. NO FURTHER TREATMENT IS PLANNED.