FDA.reportPublic FDA data

MAUDE MDR 3761786

MDR report key
3761786
Report number
2520274-2014-10927
Event key
0
Event type
3
Date received
2014-04-21
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
LINDA PLEWS
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPLANT, FIXATION DEVICE, SPINALSYNTHES (USA)JDNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-2101. R

Event Narratives#

D

Patient 1

THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CABRERA, E., ALEJANDRO, L., (2011), PRELIMINARY CLINICAL-RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURE, EUROPEAN SPINE JOURNAL, 20:2067?2095. DOI 10.1007/S00586-011-2013-1. THE INCIDENCE OF VERTEBRAL OSTEOPOROTIC FRACTURES IS INCREASING. IT IS NOW THE MOST COMMON OSTEOPOROTIC FRACTURE AND AN IMPORTANT PUBLIC HEALTH PROBLEM INVOLVING CONSIDERABLE HEALTHCARE COST. IN THIS STUDY, THE PRELIMINARY CLINICAL AND RADIOLOGIC RESULTS OF KYPHOPLASTY WITH VERTEBRAL STENTING ARE REPORTED A RETROSPECTIVE STUDY OF 31 PATIENTS WITH A LUMBAR OR LOWER THORACIC VERTEBRAL FRACTURE AT A SINGLE LEVEL WITH POSTERIOR WALL INTEGRITY, TREATED BY KYPHOPLASTY WITH VERTEBRAL BODY STENTING. MEAN AGE WAS RANGE WAS 69 THROUGH 87 YEARS. MEAN FOLLOW-UP WAS 12 TO 27 MONTHS. COMPLICATIONS THAT WAS REPORTED ARE THREE CASES OF ASYMPTOMATIC CEMENT LEAK OCCURRED AND TWO CASES OF VERTEBRAL FRACTURE IN SEGMENTS ADJACENT TO THE TREATED VERTEBRA. THERE WERE NO INFECTIONS OR COMPLICATIONS. NO REOPERATIONS WERE NEEDED. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. VERTEBRAL FRACTURE IN SEGMENTS ADJACENT TO THE TREATED VERTEBRA.

N

Patient 1

DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. CABRERA, E., ALEJANDRO, L., (2011), PRELIMINARY CLINICAL-RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURE, EUROPEAN SPINE JOURNAL, 20:2067?2095. DOI 10.1007/S00586-011-2013-1. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.