FDA.reportPublic FDA data

MAUDE MDR 9680003

MDR report key
9680003
Report number
1030489-2020-00151
Event key
0
Event type
3
Date of event
2019-12-24
Date received
2020-02-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACIE ZIEMBA
Address
1800 PYRAMID PLACE MEMPHIS TN 38132 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KYPHON HV-R BONE CEMENTCEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INCNDNNAC01B0010061040N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0701. O

Event Narratives#

N

Patient 1

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT L2. POST-OP, PATIENT WAS EXPERIENCING AN ACUTE INFLAMMATORY RESPONSE AND EXTREME PAIN AT THE SITE OF A KYPHOPLASTY SURGERY. WHILE THE DOCTOR IS NOT CERTAIN THAT CEMENT IS THE CAUSE OF THIS BUT HE WAS CONCERNED THAT IT MIGHT BE RELATED.