FDA.reportPublic FDA data

MAUDE MDR 8139188

MDR report key
8139188
Report number
9611053-2018-00221
Event key
0
Event type
3
Date received
2018-12-06
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. KARL NITTINGER
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
1MACHTOU PLUGGER 001/002PLUGGER, ROOT CANAL, ENDODONTICDENTSPLY VDW GMBHEKRNAV041063001002UNKY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-060

Event Narratives#

N

Patient 1

WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

D

Patient 1

IN THIS EVENT, IT WAS REPORTED THAT A MACHTOU PLUGGER SEPARATED. THE BROKEN PIECE HAS BEEN RETRIEVED AND NO INJURY RESULTED.