FDA.reportPublic FDA data

MAUDE MDR 3855659

MDR report key
3855659
Report number
1526439-2014-11583
Event key
0
Event type
3
Date received
2014-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
ANITA BARNICK
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SABER I/F CAGESPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEMDEPUY SYNTHES SPINEMCVR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-0901. R

Event Narratives#

D

Patient 1

POST MARKET SURVEILLANCE REVIEW OF LITERATURE FOUND REPORT OF CEREBRAL SPINAL FLUID (CSF) LEAKAGE INVOLVING A SABER I/F CAGE. ARTICLE TITLE: ?COMPARISON OF UNILATERAL VERSUS BILATERAL INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION IN DEGENERATIVE LUMBAR DISEASES (XUE, H.) PUBLICATION DATE JAN 2012.? CLINICAL FINDINGS DETERMINED BY MEDICAL SAFETY AND COMPLAINT MANAGEMENT: N=4, CSF LEAK. THE FOLLOWING MFG MEDWATCH REPORTS ARE BEING FILED FOR THE FOUR PATIENTS/EVENTS. 1526439-2014-11576, 1526439-2014-11581, 1526439-2014-11582, 1526439-2014-11583.

N

Patient 1

NO FOLLOW UP REPORT IS ANTICIPATED AS THE PRODUCT HAS NOT BEEN RETURNED. THE SOURCE OF THE REPORT IS THE FOLLOWING LITERATURE SOURCE: ?COMPARISON OF UNILATERAL VERSUS BILATERAL INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION IN DEGENERATIVE LUMBAR DISEASES (XUE, H.) PUBLICATION DATE JAN 2012.? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.