FDA.reportPublic FDA data

MAUDE MDR 467686

MDR report key
467686
Report number
2029012-2003-00021
Event key
0
Event type
3
Date of event
2003-05-24
Date received
2003-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CAROL BERARD
Address
181 TECHNOLOGY DR IRVINE CA 92618 US
Phone
949-949-9494
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNERGY SPINAL SYSTEMORTHOPEDIC IMPLANTINTERPORE CROSS INTL.KWONA600731554K950709YYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-06-2001. H

Event Narratives#

D

Patient 1

PT ORGINALLY HAD SURGERY IN 2003. THE PT WAS EXPERIENCING PAIN POST-OPERATIVELY. POST-OP X-RAYS WERE PERFORMED AND REVEALED THAT THE LEFT ROD HAD SLIPPED 2" CEPHALLY. PT HAD A SECOND SURGERY IN 2003. DURING THE REVISION, BOTH SIDES WERE FOUND TO BE LOOSE. NEW VLS CAPS AND A ROD WERE PUT IN.