MAUDE MDR 6144328

MDR report key
6144328
Report number
MW5066481
Event key
0
Event type
3
Date of event
2016-04-01
Date received
2016-12-01
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COFLEX CLAMPCOFLEX CLAMPPARADIGM SPINE, LLC.GDJ* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-0101. O

Event Narratives#

D

Patient 1

I HAD COFLEX CLAMP INSTALLED ON L2 IN (B)(6) 2016. MY PAIN IS BETTER BUT I FEEL A CLICKING IN MY BACK AND IT'S NOT ISOLATED TO ANY ONE MOVEMENT, AND IT CAUSES ME PAIN, SOMETIMES STOPS ME IN MY TRACKS, IT EVEN HURTS WHEN I'M TURNING OVER IN BED. I WENT TO MY SURGEON IN (B)(6) AND TOLD HIM ABOUT IT, AND HE SENT ME TO PHYSICAL THERAPY AND PHYSICAL THERAPIST DOCTOR TOLD ME THEY COULDN'T DO ANYTHING FOR ME. I WENT BACK TO THE SURGEON AGAIN AND HE AGAIN REFERRED ME TO GO BACK TO PHYSICAL THERAPY AND SAID HE DISAGREES WITH THE PHYSICAL THERAPIST'S DIAGNOSIS. I ALSO HAVE A LARGE AMOUNT OF GAS LOCATED IN AN AREA OF WHERE THE SURGERY TOOK PLACE, AND I WENT TO SEE A GASTROLOGIST AND HE SAID IT WAS NORMAL, SO I THOUGHT THE GAS WAS CAUSING MY PAIN AND THAT WAS WHAT WAS MOVING AROUND IN ME, BUT APPARENTLY THAT'S NOT WHAT IT IS SO I'M STILL WONDERING WHAT'S GOING ON. I WANT TO KNOW IF THERE'S ANY OTHER PEOPLE THAT ARE REPORTING THIS OUT THERE.