Description of Event or Problem · 1
THE MEDICAL DEVICE IN QUESTION IS A STRYKER INTERVENTIONAL SPINE DISCMONITOR DISCOGRAPHY PROBE (B)(4) LOT# 09292012. THIS DEVICE ALONG WITH A STRYKER PRINTER FOR USE WITH THE DISCMONITOR (B)(4) WERE PURCHASED FROM OUR STRYKER SALES REPRESENTATIVE (B)(4) AND THE FIRST FEW THAT WERE USED, WERE FULLY FUNCTIONAL. HOWEVER, (B)(6) 2010 AND TWO PREVIOUS DATES, THE DISCMONITORS MALFUNCTIONED AND DID NOT STORE ANY DATA FROM THE DISCOGRAM PROCEDURES. THIS PRODUCT ERROR COULD HAVE CAUSED THREE PATIENTS TO HAVE ENDURED THE DISCOGRAM PROCEDURE, WITHOUT ANY RESULTS. IN THE FIRST CASE THE PERFORMING PHYSICIAN, WAS ABLE TO RECOVER THE PRESSURE LEVELS AND OTHER SUCH DATA, FROM MEMORY. IN THE MOST PREVIOUS TWO CASES, THE PERFORMING PHYSICIAN WAS QUITE CAUTIOUS BECAUSE OF THE FIRST PRODUCT FAILURE, AND RECORDED HIS FINDINGS AT EACH LEVEL MANUALLY. THE STRYKER SALES REPRESENTATIVE WAS IMMEDIATELY NOTIFIED OF THE PROBLEM. UNFORTUNATELY, HE MADE NO ATTEMPT TO SOLVE THE PROBLEM OR COME BY TO SEE FOR HIMSELF THE PRODUCT FAILURE. HE SIMPLY STATED THAT HE HAD HEARD OF THIS PROBLEM BEFORE AND REALLY WAS NOT SURE WHAT CAUSED THE PRODUCT TO FAIL. HE SAID THAT IT COULD BE A BATTERY PROBLEM. AFTER NO SUCCESS IN SOLVING THIS PROBLEM WITH THE SALE REPRESENTATIVE, (B)(4), WITH STRYKER WAS CONTACTED AT (B)(4) AND AT (B)(4). AFTER EXPLAINING THE SITUATION, HE STATED THAT HE WOULD CONTACT (B)(4) AND SEND HIM OUT TO TRY AND RECTIFY THE PROBLEM AND SEE WHY THE DEVICES WERE NOT FUNCTIONING. TWO DAYS LATER, (B)(4) CALLED TO TELL ME THAT HE DID NOT APPRECIATE ME CONTACTING HIS BOSS AND THAT THE PROBLEM WAS NOT ONE THAT HE COULD FIX. I CAN NOT GET ANY ASSISTANCE FROM STRYKER ON THIS MATTER, AND CONTINUE TO HAVE PRODUCT FAILURE. WE WILL REVERT BACK TO USING THE DISCOGRAM DEVICE THAT WE USED PRIOR, FOR THE PROTECTION OF OUR PATIENTS. THE CONCERN REMAINS THAT AN INFERIOR MEDICAL DEVICE IS BEING SOLD, AND ONCE PURCHASED, NO ONE FROM THE COMPANY IS THERE TO STAND BY THE PRODUCT.