Description of Event or Problem · 1
ON (B)(6) 2007, SURGEON DR. (B)(6) PERFORMED A SACROILIAC JOINT FUSION L5-S1 USING THE INFUSE BONE GRAFT/LT-CAGE (PMA 000058) IN COMBINATION WITH THE TSRH (K052144) AND INSTRUMENTATION TO MANNER NOT CLEARED FOR USE BY THE FDA. RATHER THAN IMPLANTING THE LT-CAGE VIA THE APPROVED ANTERIOR APPROACH, SURGEON ELECTED TO USE THE TSRH INSTRUMENTATION TO GUIDE THE LT-CAGE FROM A TRANS-SACRAL APPROACH. SURGEON APPLIED THE RHBMP-2 COMPONENT IN MANNER, CONTRAINDICATED ON INSTRUCTIONS FOR USE (IFU) MANUAL, I.E. OUTSIDE OF THE LT-CAGE IN ADDITION TO PACKAGING THE HOLLOW CAVITY OF THE LT-CAGE WITH THE RHBMP-2. ADDITIONALLY ANOTHER PEEK CAGE OF UNKNOWN ORIGIN WAS IMPLANTED AND ALSO PACKED WITH RHBMP-2. PT SUFFERED SEVERE POST-OPERATIVE COMPLICATIONS INCLUDING BUT NOT LIMITED TO ECTOPIC BONE GROWTH ENCROACHING ON NERVE ROOTS AND SURROUNDING TISSUE PROXIMAL TO IMPLANTATION OF DEVICE(S), NECESSITATING REVISION SURGERY TO EXPLANT ALL DEVICES, WITH EXCEPTION OF THE LT-CAGE ON OR ABOUT (B)(6) 2008. PT CONTINUES TO SUFFER FROM COMPLICATIONS CURRENTLY BEING MANAGED THROUGH PAIN MEDICATIONS. MEDICAL RECORDS APPEAR TO HAVE BEEN ALTERED IN THE DEVICE IMPLANT RECORD(S) ARE MISSING. POST-OPERATIVE RADIOGRAPH FROM SECOND REVISION SURGERY INDICATES THAT ALL DEVICES BUT THE LT-CAGE WERE EXPLANTED. IT IS LIKELY THAT THE SECOND SPACER/CAGE IMPLANTED DURING FIRST SURGERY FAILED BY NOT CONTAINING THE RHBMP-2 COMPONENT AND THEREBY LEAKING INTO SURROUNDING AREAS CAUSING ECTOPIC BONE GROWTH. BUT THE ORIGINS OF THE DEVICE, ITS SPECS, MODEL, LOT NUMBER ARE UNKNOWN. IN SURGEON'S DEPOSITION, SURGEON ADMITS UNDER PENALTY OF PERJURY THAT HE DID NOT KNOW WHAT HE WAS DOING. FDA REQUIRES THAT USE OF THESE DEVICES BE SOLD ONLY TO SURGEONS WHO HAVE BEEN TRAINED TO USE THEM.