FDA Adverse Event Injury Summary report: N

DYNESYS

MDR report key: 1349389 · Received March 18, 2009

Report

Report Number
9613350-2009-00125
Event Type
Injury
Date Received
March 18, 2009
Date of Event
February 5, 2009
Report Date
February 5, 2009
Manufacturer
ZIMMER GMBH
Product Code
NQP
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
RI, US

Narratives

Description of Event or Problem · 1

THE PT WAS REPORTED: I HAD A DYNESYS IMPLANT IN 2008, AND IT WAS SUCCESSFUL FOR ABOUT A MONTH. ABOUT FOUR MONTHS LATER, I COULDN'T STAND UP STRAIGHT WITHOUT SWAYING BACK AND FORTH. MY DOCTOR, USED ALLOGRAFT BONE AND POST OP RECOVERY WAS ABOUT 12 WEEKS WITHOUT A WALKER OR CANE. FORTUNATELY, I WAS ABLE TO FIND A VERY QUALIFIED SURGEON TO HELP ME WITH MY PAIN THROUGH WEBSITE. THE DOCTOR IS LISTED IN YOUR RECOMMENDATIONS FOR COMPLEX SPINE SURGERY. HE TOLD ME THAT WHEN HE WENT IN TO DO THE SUBSEQUENT SURGERY, THAT ALL HE DID TO REMOVE THE DYNESYS WAS LIFT THE CORD WHICH WAS FREE FROM THE SCREW. IT APPEARED THAT THE SCREW HAD DONE SOME DAMAGE TO THE BONE TISSUE AND THE SCREW WAS ACTUALLY JUST FLOATING IN THE CIRCLE WHICH IS ONCE FIT. MY DOCTOR REMOVED THE IMPLANT COMPLETELY AND IMPLANTED A FULL CAGE, I BELIEVE MANUFACTURED BY YOU. HE SAID THAT IT SHOULD OF BEEN THE ONE OF CHOICE FROM THE BEGINNING. MY QUESTION TO YOU IS, MY FIRST DOCTOR WAS NOT LISTED ON YOUR SITE AS HAVING BEEN TRAINED THROUGH YOUR SEMINARS (OF COURSE, 20/20 HINDSIGHT TO CHECK YOUR WEBSITE OUT.) BUT HOW WAS HE ABLE TO OBTAIN YOUR PRODUCT AND SPECIALIZED TOOLS TO PERFORM A SURGERY THAT HE WASN'T PROPERLY TRAINED? IF HE WERE, I WOULDN'T OF HAD TO AND CONTINUE TO GO TO PHYSICAL THERAPY, AQUATICS, PAIN, ETC. I SURE WOULD APPRECIATE YOUR OPINION AS TO HOW THIS COULD HAVE HAPPENED. DOES THE DYNESYS HAVE THAT HIGH OF A FAILURE RATE? I AM JUST CONFUSED AND UPSET AND WOULD SURELY LIKE SOME ANSWERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DYNESYS UNKNOWNDYNESYS NQP ZIMMER GMBH UNKNOWNDYNESYS

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R