FDA Adverse Event Injury Summary report: N

INTERBODY DEVICE/PLATE /SCREWS

MDR report key: 7063484 · Received November 28, 2017

Report

Report Number
MW5073586
Event Type
Injury
Date Received
November 28, 2017
Date of Event
February 26, 2016
Report Date
November 22, 2017
Manufacturer
ZAVATION
Product Code
KWQ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A TWO LEVEL ANTERIOR CERVICAL FUSION ON (B)(6) 2016 DUE TO A CAR ACCIDENT. MONTHS AFTER MY FUSION MY PAIN CONTINUED TO BE HORRIBLE. I WOULD RETURN TO MY SURGEON TIME AND TIME AGAIN ONLY TO BE REFERRED TO PAIN MANAGEMENT AND PHYSICAL THERAPY. PAIN MANAGEMENT DID TRIGGER POINT INJECTIONS AND TWO EPIDURAL INJECTIONS. I DID MANY SESSIONS OF PHYSICAL THERAPY. NOTHING WOULD GIVE ME RELIEF FOR MORE THAN A COUPLE OF DAYS. I HAVE TO GET MESSAGES ON A REGULAR BASIS JUST TO GET THE PAIN TO EASE UP A LITTLE TO FUNCTION. I RETURNED TO WORK PART TIME ON (B)(6) 2016. I AM CURRENTLY STILL ONLY PART TIME AND WORKING PART TIME IS EXTREMELY DIFFICULT. MY PRIMARY CARE DR EVEN STARTED GIVING ME INJECTIONS INTO MY LEFT SHOULDER AND NECK EVERY 7-10 DAYS. IN (B)(6) 2017, SHE SENT ME FOR A MYELOGRAM. THE MYELOGRAM REPORT STATED THAT MY FUSION DID NOT FUSE. THE REPORTS ACTUAL WORDS WERE "ANTERIOR CERVICAL FUSION FROM C5 THROUGH C7. THERE IS INCOMPLETE INCORPORATION OF THE INTERBODY DEVICES. THERE IS INCOMPLETE FUSION OF THE INTERBODY DEVICES." MY MYELOGRAM SHOWED ME WHERE THE PLATE AND SCREW AT THE TOP OF MY FUSION IS NOT AGAINST THE SPINE. HE SAID THIS WAS MOST LIKELY THE REASON I AM IN SUCH BAD PAIN (THAT GETS WORSE EACH DAY). SO MUCH OF MY PAIN HAS BEEN INFLAMMATION ESPECIALLY IN MY LEFT SHOULDER. I WILL BE SCHEDULED IN (B)(6) 2018 FOR A REVISION SURGERY. MY SURGEON WILL REMOVE THE CERVICAL HARDWARE AND REDO THE FUSION. THIS TIME WE WILL MOST LIKELY HAVE TO DO THE LEVEL ABOVE AS WELL DUE TO THE STRAIN ON THE SPINE. THE LEVEL ABOVE IS STARTING TO HERNIATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
842162 INTERBODY DEVICE/PLATE /SCREWS SPINAL SYSTEM KWQ ZAVATION

Patients

Seq Age Sex Outcome Treatment
1 Other