LINQ
Received Jan 30, 2024 · Event occurred Nov 16, 2022
Report MW5150905 · MDR key 18613836
Device
Generic name
Sacroiliac Joint Fixation
Manufacturer
Paintec / PainteqPatient
64 YR · Unknown
- Failure of Implant
- Pain
- Joint Laxity
- Failure of Implant
- Pain
- Joint Laxity
Narrative
Description of Event or Problem
THIS IS REGARDING THE LINQ BY PAINTEC SI JOINT FUSING DEVICE. I CONTINUED WITH THE SAME PAIN AS BEFORE THE PROCEDURE AND AFTER TEN MONTHS REQUESTED A CT SCAN WHICH SHOWED THAT THE SI JOINT NEVER FUSED NOR SHOWED ANY SIGNS OF FUSING. FROM MY EXPERIENCE, THIS SMALL DEVICE IS NOT SUFFICIENT TO STABILIZE THE LARGEST JOINT IN THE BODY FROM MOVEMENT WHILE IT IS SUPPOSED TO FUSE. IT IS BECAUSE I HAD TOO MUCH MOVEMENT IN THE JOINT, DEGENERATIVE, THAT I HAD PAIN TO BEGIN WITH. I HAD THE LINQ PROCEDURE DONE BY DR. (B)(6), IN (B)(6), WHO IS ONE OF THEIR MOST EXPERIENCED INTERVENTIONAL RADIOLOGISTS THAT WAS TRAINED BY PAINTEC, AND IN FACT THEY HAVE HIM FEATURED IN A VIDEO SALES PRESENTATION ON THEIR WEBSITE. AFTER WAITING ALMOST A YEAR IN CONTINUAL PAIN, I HAD A REVISION DONE BY DR. (B)(6) IN (B)(6) AND HE USED SI LOK, THREE SCREWS. THE POSTOP PAIN WAS LESS AND I WAS PAIN FREE IN 7 WEEKS. IT IS MY UNDERSTANDING FROM THAT LINQ HAD FAILED OTHER PEOPLE AS WELL. THIS EXPERIENCE RESULTED IN MY MEDICARE PAYING TWICE, AND MONEY AND TIME WASTED FOR ME AS WELL. I CAN BE REACHED AT (B)(6).