FDA.reportPublic FDA data

MAUDE MDR 4862596

MDR report key
4862596
Report number
2320721-2015-00006
Event key
0
Event type
3
Date received
2015-06-18
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
HELEN LEWIS
Address
221 W PHILADELPHIA ST SUSQUEHANNA COMMERCE CTR W., STE 60 YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GUTTACORE OBTURATORSGUTTA-PERCHADENTSPLY TULSA DENTAL SPECIALTIESEKMA1702P00425000000072473N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-180

Event Narratives#

D

Patient 1

IN THIS EVENT A DENTIST REPORTED THAT HE CAN BRING GUTTACORE OBTURATORS TO ONLY 80% IN THE ROOT CANAL AND THEN THE OBTURATOR BREAKS OFF. THE EVENT OUTCOME IS UNK AS OF THIS MDR EVAL. ADD'L INFO HAS BEEN REQUESTED BUT IS NOT YET AVAILABLE.

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 POSSIBLE CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

N

Patient 1

THIS REPORT WAS SUBMITTED IN ERROR. THIS TYPE OF MALFUNCTION WOULD NOT BE LIKELY TO RESULT IN A SERIOUS INJURY. THE CLINICIAN WOULD SIMPLY ADD TO THE FILLING MATERIAL WITH ANOTHER OBTURATOR.