FDA.reportPublic FDA data

MAUDE MDR 7880043

MDR report key
7880043
Report number
1030489-2018-01246
Event key
0
Event type
3
Date received
2018-09-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1X-STOP INTERSPINOUS SPACERPROSTHESIS, SPINOUS PROCESS SPACER/PLATEMEDTRONIC SOFAMOR DANEK USA, INCNQONA1-22122275781Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-1701. H; 2. R

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 TREATMENT AT L4/L5 LEVELS. POST-OPERATIVELY, THE PATIENT BEGAN TO EXPERIENCE RECURRENCE OF NEUROGENIC CLAUDICATION. DIAGNOSTIC IMAGE STUDIES REVEALED DISPLACEMENT OF THE SPACER FROM THE INTERLAMINARY SPACE. AS A RESULT, A REVISION SURGERY WAS PERFORMED FOR REMOVAL FOLLOWED BY LUMBAR DECOMPRESSION AND IMPLANTATION OF A NEW SPACER. THE ALLEGED SPACER WAS REMOVED BY LOOSENING THE LOCKING SCREWS ON ONE OF THE WING CLAMPS AND REMOVED IN TWO PIECES AND REPORTEDLY INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.