FDA Adverse Event Injury Summary report: N

DEPUY SPINE, INC

MDR report key: 889512 · Received August 2, 2007

Report

Report Number
MW5003297
Event Type
Injury
Date Received
August 2, 2007
Date of Event
May 5, 2005
Product Code
MJO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PRIOR TO THE IMPLANT, I WAS INFORMED BY MY DR THAT I WAS A PRIME CANDIDATE, MEETING ALL THE CRITERIA FOR THE CHARITE DISC. I WAS TOLD THAT I WAS TOO YOUNG TO GET A LUMBAR FUSION, BECAUSE IT WOULD SEVERELY LIMIT MY FLEXIBILITY AND QUALITY OF LIFE. I WAS TOLD IN NO UNCERTAIN TERMS THAT THE CHARITE DISC WOULD BE ONE HUNDRED PERCENT EFFECTIVE IN RELIEVING MY LOWER BACK, LEFT LEG, BUTTOCK AND FOOT PAIN. THIS WOULD BE SUPPOSEDLY ACCOMPLISHED BY THE NATURAL MOTION THE CHARITE WOULD ALLOW IN PLACE OF A RIGID FUSION. I WAS DIAGNOSED WITH DEGENERATIVE DISC DISEASE AT THE L5-S1 LEVEL. MY PROBLEMS STARTED SHORTLY AFTER THE CHARITE ARTIFICIAL DISC WAS IMPLANTED. TO THIS DAY, I CONTINUE TO EXPERIENCE LOWER BACK PAIN AND STIFFNESS. I STILL HAVE PAIN THAT SHOOTS DOWN MY LEFT BUTTOCK, LEG AND FOOT CONSTANTLY. IT DOES NOT RELENT. I EXPERIENCED SLEEP DEPRIVATION EVERY NIGHT, EVEN WITH PAIN KILLERS. I ALSO STARTED EXPERIENCING FREQUENT URINATION THROUGHOUT THE DAY AND NIGHT. I WAS INFORMED BY MY UROLOGIST THAT WAS A NEUROLOGICAL PROBLEM CAUSED BY THE CHARITE IMPLANT. THE BLADDER HAD TO BE MOVED DURING THE SURGERY DUE TO THE FACT THAT THE SURGICAL APPROACH WAS THROUGH THE LOWER ABDOMEN AREA. SO, NOW I TAKE DITROPAN, A DRUG PEOPLE TWICE MY AGE TAKE TO HELP WITH THIS PROBLEM CREATED BY CHARITE DISC. I NOW LIVE WITH THE DREAD OF KNOWING THAT SOMEDAY THIS CHARITE DISC WILL HAVE TO BE REMOVED. IT IS LIKE HAVING A TICKING TIME BOMB IN YOUR SPINE; WILL IT DISLODGE OR WEAR OUT? I AM NOW PERMANENTLY DISABLED WITH NO SIGN OF RELIEF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEPUY SPINE, INC CHARITE MJO

Patients

Seq Age Sex Outcome Treatment
1 YR Other| S