MAUDE MDR 1679314

MDR report key
1679314
Report number
1423380-2010-00004
Event key
0
Event type
3
Date of event
2010-04-05
Date received
2010-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LISA BARTAKOVICS
Address
675 HEATHROW DR LINCOLNSHIRE IL 60069 US
Phone
847-847-8474
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROGENY PREVAMIDMARK CORPMUHPREVAP7017R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-05-040

Event Narratives#

D

Patient 1

A TECHNICAL SUPPORT FROM DEALER REPORTED THAT THE MECHANICAL STRUCTURE OF A PREVA INTRA-ORAL X-RAY UNIT, (B)(4), SEPARATED FROM THE WALL. NO INJURY WAS REPORTED.