Description of Event or Problem · 1
MY NAME IS (B)(6) AND I HAD A SURGERY IN WHICH A MEDICAL DEVICE, SPECIFICALLY SCREWS USED IN THE SAVANNAH-T PEDICLE SCREW SYSTEM, BROKE IN A VERY SHORT PERIOD AFTER THE SURGERY. AMENDIA IS THE COMPANY WHO MANUFACTURES, SELLS, AND ENDORSES THESE SCREWS. ALTHOUGH I HAVE MADE NUMEROUS ATTEMPTS TO APPEAL TO AMENDIA AND NUMEROUS ATTEMPTS TO SECURE EFFECTIVE LEGAL COUNSEL AND REP. MY APPEAL TO AMENDIA AND THEIR LAWYERS HAS CONTINUED TO BE IGNORED AND WHEN THEY DID ADDRESS ME, THEIR LAWYERS DENIED ANY RESPONSIBILITY. FURTHER, ANY LAW FIRM THAT I HAVE SPOKEN TO ABOUT MY CASE HAS EITHER ABANDONED MY CASE BECAUSE THEY DID NOT WANT TO GO TO LITIGATION AND/OR TRIAL OR THEY HAVE BEEN TIMID ABOUT PROCEEDING WITH THE CASE IN A TIMELY MANNER. THE COPY OF THE LETTER THAT I SENT TO AMENDIA DETAILS THE FOLLOWING: MY PAIN AND SUFFERING IN THE AFTERMATH OF THE BOTCHED SURGERY, MY STRUGGLE TO GET INSURANCE FOR THE CORRECTIVE/REVISION SURGERY, THE PERIOD OF TIME AFTER MY CORRECTIVE SURGERY, MY STRUGGLE TO GET HELP, LEGAL REPRESENTATION, AND EFFECTIVE REPRESENTATION IN THIS MATTER. I ASK THAT YOU PLEASE REVIEW IT AND I ASK THAT IT SERVE DUE TO THE FOLLOWING PURPOSES: A FORMAL COMPLAINT AGAINST THE COMPANY, AND ASSISTANCE IN HAVING MY CLAIM HEARD AND ADDRESSED, AND ADVOCACY. THE PLAINTIFF, (B)(6), UNDERWENT SURGERY ON AUGUST 17, 2015 FOR A HERNIATED DISC/L5-S1 DISCECTOMY FUSION WITH OBLIQUE LATERAL LUMBAR INTERBODY CAGE 12X32 MM WITH VIVEX BONE GRAFT. THE SURGEON WAS DR (B)(6) AND THE SURGERY WAS PERFORMED IN (B)(6). FOLLOWING THE SURGERY, THE PLAINTIFF EXPERIENCED SEVERE PAIN AND FELT THAT HE WAS NOT HEALING, SO HE FOLLOWED UP WITH A VISIT TO DR (B)(6). DR (B)(6) ORDERED AN X-RAY AND ASSURED THE PLAINTIFF THAT HE WAS HEALING AND THAT THE SAVANNAH-T PEDICLE SCREW SYSTEM THAT WAS USED IN THE SURGERY WAS INTACT AND FUNCTIONING. AFTER THE VISIT, THE PLAINTIFF MADE A REQUEST TO DR (B)(6) TO SEE THE X-RAYS AND MADE A FURTHER REQUEST THAT THE X-RAYS BE SENT TO HIM; HOWEVER, DR (B)(6) DID NOT RESPOND TO HIS REQUEST AT THE TIME OF THE REQUEST (IT IS IMPORTANT TO NOTE THAT THE X-RAYS FROM THE F/U VISIT AFTER THE SURGERY WERE FINALLY OBTAINED AND THEY SHOWED THE FRACTURED SCREW). AFTER APPROX 3 MONTHS OF CONSTANT PAIN AND NOT BEING ABLE TO POSTURE HIMSELF, THE PLAINTIFF ONCE AGAIN SOUGHT MEDICAL TREATMENT FOR THE SEVERE AND DEBILITATING LOWER BACK PAINS THAT HE WAS EXPERIENCING. ON (B)(6) 2015, THE PLAINTIFF VISITED UNIVERSITY OF (B)(6) EMERGENCY ROOM AND UPON EXAMINATION, IT WAS REVEALED THAT THE PLAINTIFF'S LEFT S1 PEDICLE SCREW HAD FRACTURED. THE DR WHO DISCOVERED AND INFORMED THE PLAINTIFF OF THE FRACTURED SCREW WAS DR (B)(6). THE PLAINTIFF CONTINUED TO EXPERIENCE PAIN AND COULD NOT SEEK MEDICAL CARE BECAUSE HE DID NOT HAVE MEDICAL INSURANCE AND COULD NOT AFFORD MEDICAL CARE. THE PLAINTIFF CONTACTED THE DOCTOR, DR (B)(6), WHO PERFORMED THE OPERATION AND AMENDIA (NOW KNOWN AS SPINAL ELEMENTS) TO DISCUSS THE FRACTURED SCREW; HOWEVER, NEITHER PARTY WOULD RESPOND OR ACKNOWLEDGE THE PLAINTIFF'S PROBLEM OF THE FRACTURED SCREW IN THE PLAINTIFF'S BODY. THE PLAINTIFF WAS ABLE TO SECURE INSURANCE IN 2017 AND ABOUT 6 MONTHS THEREAFTER, HE WAS ABLE TO SEEK CARE FROM DR (B)(6) WHO EXAMINED HIM AND ADVISED HIM THAT A REVISION SURGERY WOULD BE NECESSARY. THE PLAINTIFF WAS ADVISED THAT THIS REVISION WOULD INCLUDE THE REMOVAL OF THE BROKEN/FRACTURED SCREWS AND REPLACEMENT OF THOSE SCREWS AND ANY FURTHER ADD'L HARDWARE THAT MAY BE NEEDED TO STABILIZE HIM AND GIVE HIM THE BEST POSSIBLE OUTCOME IN TERMS OF MOBILITY. IN 2017, DR (B)(6) PERFORMED A REVISION SURGERY IN (B)(6). THE SAVANNAH-T PEDICLE SCREW SYSTEM WAS REMOVED AND REPLACED. AS DR (B)(6) ADVISED ADD'L HARDWARE (SCREWS) WERE NEEDED AS A CORRECTIVE MEASURE TO ENSURE STABILITY AND THE BEST POSSIBLE OUTCOME OF MOBILITY. AMENDIA'S DEFECTIVE SAVANNAH-T PEDICLE SCREW SYSTEM AND ALL OF ITS COMPONENTS HAVE BEEN RECOVERED AND EXAMINED BY AN EXPERT. FURTHER, THE SCREWS BEING MADE OF A DEFECTIVE MATERIAL IS IN VIOLATION OF THE REQUIREMENTS OF THE FOOD AND DRUG ADMINISTRATION (FDA). UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT DR (B)(6), DURING THE TIME HE PERFORMED SURGERY ON THE PLAINTIFF, (B)(6), WAS SERVICING AS A BOARD MEMBER AND/OR REP FOR AMENDIA (NOW KNOWN AS SPINAL ELEMENTS). IT WAS ALSO NOTED THAT DR (B)(6) WITHHELD THE X-RAYS THAT WERE TAKEN DURING THE F/U VISIT WITH THE PLAINTIFF WHEN THEY WERE REQUESTED. IT SHOULD BE FURTHER NOTED THAT DR (B)(6) DID NOT SHOW AND/OR DISCUSS THE X-RAY DURING THE VISIT WITH THE PLAINTIFF EVEN THOUGH, DURING THE VISIT, HE EXAMINED THE X-RAYS IN THE PRESENCE OF THE PLAINTIFF. DR (B)(6), IN WORKING WITH AND FOR AMENDIA, HAD LOYALTIES TO AND/OR A VESTED INTEREST IN THE COMPANY; MOREOVER, IT IS THE PLAINTIFF'S BELIEF AND HIGHLY PLAUSIBLE THAT DR (B)(6) AND AMENDIA WERE IN ALLIANCE WITH EACH IN REGARDS TO THEIR DECISIONS TO NOT ACKNOWLEDGE THE PLAINTIFF, AS A CONSUMER AND/OR CLIENT, WHO WAS EXPERIENCING THE DEFECT AND FAILURE OF AN AMENDIA PRODUCT. REF # (B)(4).