MOTECH TITANIUM SURGICAL MESH

Description of Event or Problem

DEVICE WAS IMPLANTED AND WITHIN THREE WEEKS, THE DEVICE EXTRUDED INTO THE INFERIOR VENA CAVA. ON 7/31/98, PT HEMORRHAGED W/AN ESTIMATED BLOOD LOSS OF 3500-4200 CC'S. SHE WAS TREATED W/MULTIPLE BLOOD TRANSFUSIONS. AT THE TIME OF EXPLANT AND REPAIR OF THE VENA CAVA, A BONE SCREW WAS PLACED. FIFTEEN DAYS POST EXPLANT, PT READMITTED W/BLOOD CLOTS IN BOTH LEGS AND THE INFERIOR VENA CAVA. SHE WAS HOSPITALIZED THIS TIME FOR APPROX 4 WEEKS. SHE WAS HEPARINIZED INITIALLY AND THEN PLACED ON COUMADIN. SHE HAD NG TUBE PLACED AND UNDERWENT A GREENFIELD VENA CAVA FILTER PLACEMENT. SHE SUBSEQUENTLY SUFFERED FURTHER EMBOLI AND IS NOW LEGALLY DISABLED WITH NO PERIPHERAL VISION DUE TO AN "EMBOLISM TO THE EYE." SHE WILL REMAIN ON MEDICATION. SHE REPORTS SHE HAS NEVER RECEIVED A RETURN CALL WHEN TRYING TO REACH MFR REP. SHE ALSO STATES THAT THIS DEVICE WAS NOT APPROVED FOR USE IN THE SPINE. RPTR IS FRUSTRATED THAT HER IMPLANTING PHYSICIAN "SHOWED HER A COMPLETELY DIFFERENT DEVICE ON THE BROCHURE" AND THAT IF SHE HAD KNOWN THE PROCEDURE WAS UNAPPROVED, SHE WOULD NOT HAVE HAD IT. SHE ALSO QUESTIONS HOW HER PHYSICIAN WAS ABLE TO GET THE INSURANCE CO TO PAY FOR THE PROCEDURE WHEN IT IS UNAPPROVED.