FDA.reportPublic FDA data

MAUDE MDR 8638116

MDR report key
8638116
Report number
2530069-2019-00004
Event key
0
Event type
3
Date of event
2019-05-07
Date received
2019-05-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ERIKA MARTIN
Address
1910 NORTH PENN ROAD HATFIELD PA 19440 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GENDEX EXPERT DCEXTRAORAL SOURCE X-RAY SYSTEMGENDEX DENTAL SYSTEMSEHD0.822.5214EXPERT DC65 NAY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-230

Event Narratives#

N

Patient 1

AN INVESTIGATION WAS CONDUCTED USING INTERVIEWS AND EXAMINING THREE PHOTOS OF THE UNIT, LAG BOLTS, AND WALL WHERE IT HAD BEEN ATTACHED. IT APPEARS THAT THE TOP BOLT CAME OUT OF THE WALL AND THE BOTTOM BOLT WAS BENT FROM THE WEIGHT OF THE UNIT. A ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT APPEARS THAT THE UNIT HAD BEEN MOVED SINCE THE INITIAL INSTALLATION. THE RE-INSTALL MAY HAVE DIMINISHED THE WALL STUD INTEGRITY TO SUPPORT THE UNIT. SALES OF THE EXPERT DC WERE DISCONTINUED ON JUNE 24, 2016. THIS CONCLUDES THE INVESTIGATION.

D

Patient 1

IT WAS REPORTED THAT THE UNIT FELL OFF THE WALL. IT WAS REPORTED THAT UNIT WAS CAUGHT BY THE HYGIENIST AND HIT THE PATIENT IN THE LEG, BUT THERE WAS NO INJURY REPORTED FOR THE PATIENT OR THE OPERATOR (HYGIENIST). UNIT WAS REATTACHED TO THE WALL.