FDA.reportPublic FDA data

MAUDE MDR 555233

MDR report key
555233
Report number
MW1033290
Event key
0
Event type
3
Date of event
2004-08-25
Date received
2004-09-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1JUPITER SURGICALCLASS 1 BONE TAMP & GRAFTSPECIALIZED MEDICAL DEVICESFGYJS-DC-0024210949020913NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-09-2101. O

Event Narratives#

D

Patient 1

IN 2004 AT HOSP, DR PERFORMED VETEBROPLAST OF LEVELS T12 AND L3 ON PT USING THE JUPITER LPSDS SYSTEM. UPON DELIVERY OF THE PMMA INTO T-12, THE PMMA WAS ALLOWED TO HARDEN WHILE REMAINING IN CONTACT WITH THE DISTAL END OF THE DELIVERY CANNULA. THE DISTAL CANULA TIP BECAME AFFIXED TO THE HARDENING PMMA WHILE STILL WITHIN THE VERTEBRAL BODY. WHILE ATTEMPTING TO REMOVE THE CANNULA FROM WITHIN THE HARDENED PMMA WITHIN THE VERTEBRAL BODY THE CANNULA WAS BENT AND THEN BROKEN. THE DISTAL TIP OF THE CANNULA BROKE OFF AND REMAINS ENCAPSULATED WITHIN THE PMMA WITHIN T12 VERTEBRAL BODY. THE PT IS FINE AT THIS TIME AND HAS NO ADVERSE EFFECTS.