FDA.reportPublic FDA data

MAUDE MDR 707897

MDR report key
707897
Report number
MW1038736
Event key
0
Event type
3
Date of event
2006-04-11
Date received
2006-04-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JACKSON SPINAL TABLEJACKSON TABLEORTHOPEDIC SYSTEMS, INCJFB5943**N*
2JACKSON SPINAL TABLEJACKSON TABLEORTHOPEDIC SYSTEMS, INCJFB5803**N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-04-180

Event Narratives#

D

Patient 1

THE PT WAS TRANSFERRED ON TO THE JACKSON SPINAL TABLE. THE PT WAS NOT IN CORRECT POSITION, SO THE PHYSICIAN PRESSED THE BUTTON TO TURN THE PT AND SHE FELL OFF TABLE. THE LOCKING MECHANISM IS NOT FAIL SAFE AND IF THE TURN HANDLE IS LEFT AT A CERTAIN POINT AND NOT CRANKED ALL THE WAY AROUND TO THE LOCKING POSITION, THE TABLE WILL MOVE AND THE PT WILL FALL OFF. WHEN THE HANDLE IS TURNED, THE USER DOES EXPERIENCE SOME RESISTANCE AT THIS INITIAL POINT AND IT APPEARS AS IF THE LOCK HAS LATCHED.