MAUDE MDR 7426531

MDR report key
7426531
Report number
1423380-2018-00002
Event key
0
Event type
3
Date of event
2018-03-16
Date received
2018-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
405
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ADAM FORESMAN
Address
675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PREVAUNIT, X-RAY, INTRAORALMIDMARK CORPORATIONEAPPREVAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-120

Event Narratives#

D

Patient 1

ON (B)(6) 2018 IT WAS REPORTED TO MIDMARK BY A SERVICE TECHNICIAN THAN AN X-RAY UNIT (PREVA, 76" REACH, SERIAL NUMBER (B)(4)) SEPARATED FROM THE WALL IN WHICH IT WAS SECURED. THERE WERE NO INJURIES OR CONTACT WITH ANY PERSONS AS REPORTED BY THE COMPLAINANT. NO OTHER PATIENT INFORMATION HAS BEEN DISCLOSED. THE UNIT MOUNTING WAS VISUALLY INSPECTED AT THE USER FACILITY BY THE TECHNICIAN AND PHOTOGRAPHS WERE SENT TO MIDMARK. THE TECHNICIAN SUSPECTS THERE TO BE WOOD SPLITTING ("STUD SPLIT"), HOWEVER, AFTER REMOVAL OF THE DRYWALL AT THE LOCATION WHERE THE UNIT WAS MOUNTED, IT WAS DISCOVERED THAT THE TOP LAG BOLT DID NOT FULLY PENETRATE THE STUD TO THE DEPTH REQUIRED TO SUPPORT THE WEIGHT OF THE PREVA AS IS REQUIRED PER THE MIDMARK PREVA INSTALLATION MANUAL. INFORMATION OBTAINED BY MIDMARK TECHNICAL SERVICE DURING THE CALL INDICATES THE FOLLOWING: IT IS UNKNOWN IF THE STRUCTURE HAS BEEN MODIFIED IN ANY WAY, THE WALL MOUNTING IS A SINGLE STUD WALL MOUNT, THE MIDMARK INSTALLATION GUIDE WAS NOT USED DURING INSTALL, THE STUDS ARE NOT EXPOSED, AND THE UNIT HAS A 76" REACH IN TOTAL. CONDITIONS AT THE TIME OF INSTALL ARE UNKNOWN. THE UNIT WAS MANUFACTURED 03/11/2011 AND SHIPPED ON (B)(6) 2011. PER THE INFORMATION OBTAINED FROM THE TECHNICIAN, THE TOP LAG BOLT CAME LOOSE FROM THE WALL (UNBROKEN) WHILE THE BOTTOM LAG BOLT REMAINED SECURED TO THE WALL. NO OTHER SURFACES WERE DAMAGED BY THE SEPARATION. MINOR DRYWALL DAMAGE TO THE WALL WAS REPORTED.