FDA.reportPublic FDA data

MAUDE MDR 7782904

MDR report key
7782904
Report number
3005882106-2018-00003
Event key
0
Event type
3
Date of event
2018-07-18
Date received
2018-08-14
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
MR ROBERT REITZLER
Address
2714 LOKER AVENUE WEST SUITE 100 CARLSBAD CA 92010 US
Phone
442-442-4423
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPERION IDSINTERSPINOUS SPACERVERTIFLEX, INC.NQO8MM SUPERION IDS100-9808800013R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-1401. O

Event Narratives#

D

Patient 1

PHYSICIAN REPORTS THAT A PATIENT HE IMPLANTED WITH THE SUPERION DEVICE CONTACTED HIM REGARDING ONSET OF ACUTE PAIN. PHYSICIAN EXAMINED THE PATIENT AND CONFIRMED A SPINOUS PROCESS FRACTURE. PATIENT REPORTS IT OCCURRED WHEN LINE DANCING. PHYSICIAN ADVISES HE WILL TREAT FOR PAIN ACUTELY AND FOLLOW PATIENT CLOSELY. SPINOUS PROCESS FRACTURES ARE A RECOGNIZED LOW-FREQUENCY RISK ASSOCIATED WITH THE SUBJECT DEVICE, AND LIKELIHOOD OF OCCURRENCE IS INCREASED IN THE PRESENCE OF CERTAIN KNOWN RISK FACTORS. IT IS NOT KNOWN WHETHER ANY SUCH RISK FACTOR(S) WAS (WERE) PRESENT IN THIS CASE.