FDA.reportPublic FDA data

MAUDE MDR 975482

MDR report key
975482
Report number
1030489-2008-00005
Event key
0
Event type
3
Date of event
2007-05-08
Date received
2008-01-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTINE SCIFERT, M.S.
Address
1800 PYRAMID PL MEMPHIS TN 38132 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MSD - UNK INSTRUMENTUNK INSTRUMENTMEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFGZXNAUNKUNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-01-0301. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT AN INSTRUMENT BROKE INTRAOPERATIVELY. AN X-RAY TAKEN SEVERAL WEEKS POST-OP REVEALED THAT THE BROKEN PIECE REPORTEDLY REMAINED INSIDE OF THE OPERATIVE SITE. A REVISION SURGERY WAS PERFORMED TO REMOVED THE BROKEN PIECE. NO ADD'L PATIENT COMPLICATIONS WERE REPORTED.

N

Patient 1

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.