FDA.reportPublic FDA data

MAUDE MDR 7904239

MDR report key
7904239
Report number
3005882106-2018-00006
Event key
0
Event type
3
Date of event
2018-08-22
Date received
2018-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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 INDIRECT DECOMPRESSION SYSTEMINTERSPINOUS SPACERVERTIFLEX, INC.NQO100-0110100-9810UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-2401. O

Event Narratives#

N

Patient 1

FAILURE TO RELIEVE OR COMPLETELY MITIGATE SYMPTOMS IS A RECOGNIZED RISK ASSOCIATED WITH DEVICE USE, AND IS DISCLOSED IN LABELING.

D

Patient 1

PATIENT REQUESTED TO HAVE HER SUPERION IMPLANTS EXPLANTED BECAUSE SHE STATED THAT SHE WAS "STILL EXPERIENCING PAIN LIKE BEFORE SHE HAD THE IMPLANTS." BOTH IMPLANTS WERE SUCCESSFULLY REMOVED. NO ALLEGATION OF DEVICE DEFECT OR MALFUNCTION WAS MADE. FAILURE TO RELIEVE OR COMPLETELY MITIGATE SYMPTOMS IS A RECOGNIZED RISK ASSOCIATED WITH USE OF THE DEVICE, AND IS DISCLOSED IN LABELING.