FDA Adverse Event Injury Summary report: N

KYPHOPLASTY CEMENT

MDR report key: 1013912 · Received March 12, 2008

Report

Report Number
MW5005873
Event Type
Injury
Date Received
March 12, 2008
Date of Event
February 11, 2008
Report Date
March 12, 2008
Product Code
LOD
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2008, MY MOTHER UNDERWENT A PROCEDURE TO CORRECT A COMPRESSED VERTEBRAE CALLED KYPHOPLASTY. THE PAIN SHE HAD WAS RELIEVED IMMEDIATELY, BUT FIVE DAYS LATER, SHE STARTED EXPERIENCING HALLUCINATIONS, INCLUDING CONVERSATIONS WITH PEOPLE NOT THERE, BUGS ON THE CEILING, HOLDING OBJECTS THAT WEREN'T THERE. SHE ALSO WAS IRRITABLE, SHORT-TEMPERED, AND FITFULL, WHILE SLIPPING IN AND OUT OF SLEEP. AFTER CONSULTING MANY DOCTORS, HER DOCTOR ADMITTED HE THOUGHT IT WAS A REACTION TO THE SOLVENT USED IN THE CEMENT, AND HER'S WAS THE THIRD CASE, INCLUDING HIS OWN MOTHER-IN-LAW, THAT HAD SIMILAR REACTIONS AFTER THE SAME PROCEDURE. MY MOTHER HAD MANY OTHER MEDICAL PROBLEMS AT THE TIME, AND DID DIE SIXTEEN DAYS LATER. WE DON'T BELIEVE THIS REACTION WAS THE PRIMARY CAUSE OF HER DEATH, BUT MAY HAVE CONTRIBUTED TO HER DEMISE. DATES OF USE: ONE DAY IN 2008 . DIAGNOSIS OR REASON FOR USE: COMPRESSED VERTEBRAE. EVENT ABATED AFTER USE STOPPED: NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KYPHOPLASTY CEMENT NONE LOD

Patients

Seq Age Sex Outcome Treatment
1 78 YR Hospitalization| O