FDA Adverse Event Injury Summary report: N

SURGICRAFT

MDR report key: 1355786 · Received April 2, 2009

Report

Report Number
MW5010588
Event Type
Injury
Date Received
April 2, 2009
Date of Event
January 27, 2006
Report Date
March 18, 2009
Product Code
GZJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD THE STALIF TT LUMBAR DEVICE IMPLANTED AT L5-S1 LEVEL, ANTERIORLY, BY ADR IN EARLY 2009. ALTHOUGH IT ELIMINATED MY LOW BACK PAIN AT L5-S1, UNFORTUNATELY, THIS DEVICE HAS CREATED A WHOLE NEW SET OF ISSUES. I BELIEVE THE HEIGHT OF THE DEVICE JACKED UP MY SPINE TOO MUCH, AND I HAVE SEVERE CRAMPING, TIGHTENING, AND NEURAL INVOLVEMENT, INTERFERING WITH MY EVERY MOVE. I HAVE TO ADJUST MY RIGHT HIP/SI JOINT APPROXIMATELY 2 DOZEN TIMES A DAY. I HAVE SEVERE PAIN IN MY RIGHT SI JOINT & RIGHT HIP, AS WELL AS NEURAL DEFECIT ON MY RIGHT SIDE. IT ALMOST FEELS LIKE I AM CONSTANTLY HEALING. I HAVE NOTICED ATROPHY IN MY RIGHT LEG. PRIOR TO THIS SURGERY, I WAS TAKING 1/2 PERCOCET AT NIGHT FOR PAIN, SOMETIMES MORE. AFTER SURGERY, I HAVE BEEN TAKING 3/4 TO 1 TABLET OF PERCOCET AT NIGHT FOR PAIN. I TRIED GOING FOR 3 DAYS WITHOUT ANY PAIN KILLER, AND ON THAT THIRD DAY, I CANNOT EVEN FUNCTION OR THINK I'M IN SO MUCH PAIN. I HAVE REPORTED THIS TO FIRST DR SEVERAL TIMES. I HAVE SINCE SOUGHT NEUROLOGIST ANOTHER DR, AND HAS DIAGNOSED MY CONDITION AS HAVING "PSEUDARTHROSIS", WITH A CT SCAN. I GO TO A CHIROPRACTOR AT LEAST ONCE, IF NOT TWO TIMES PER WEEK, JUST TO GET THE RELIEF I NEED TO NEUROLOGICALLY FUNCTION. AT THIS TIME, I AM DESPERATELY SEEKING TO HAVE THIS DEVICE REMOVED FROM MY BODY. IT ALMOST SEEMS LIKE MY BODY IS TRYING TO REJECT THIS DEVICE. LET IT BE NOTED THAT I HAD DEVELOPED SOME SERIOUS HEMORRHOIDS IMMEDIATELY (HOURS) AFTER SURGERY, WHICH BLOOD BURSTED AND DRAINED OUT OF. I BELIEVE I AM EXPERIENCING COMPLICATIONS DUE TO THIS POLYMER DEVICE IMPLANT. I HOPE I CAN GET ANOTHER 2-3 YEARS WORKING FOR MY CURRENT EMPLOYER BEFORE I CAN NO LONGER WORK. THIS IS REALLY WEARING ON ME TREMENDOUSLY. DATES OF USE: EARLY 2006 TO PRESENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURGICRAFT STALIF TT LUMBAR DEVICE GZJ

Patients

Seq Age Sex Outcome Treatment
1 33 YR Other| R| S