Description of Event or Problem · 1
CLASS III MEDTRONIC INFUSE BONE GRAFT, APPROVED UNDER PMA [P000058] IMPLANTED IN COMBINATION WITH CLASS II INTERVERTEBRAL BODY FUSION DEVICE MEDTRONIC HOURGLASS CLEARED UNDER (510(K)) [K033296] WITH CLASS II INTERBODY FIXATION DEVICE MEDTRONIC LEGACY (510(K)) [K060203] WAS IMPLANTED INTO PATIENT VIA POSTERIOR APPROACH FOR MULTI-LEVEL LUMBAR FUSION. CONTRARY TO 21CFR888.3080 MEDTRONIC DISTRIBUTED INTO INTERSTATE COMMERCE THE COMBINATION OF DEVICES, COMPONENTS CONTRARY TO 21 CFR 888.3080 THAT REQUIRES SUCH COMBINATION OF CLASS III THERAPEUTIC BIOLOGIC (BONE MORPHOGENIC PROTEIN) AND CLASS II INTERVERTEBRAL FUSION DEVICE MUST HAVE PMA. IN THE ABSENCE OF PMA, THE COMBINATION OF COMPONENTS/DEVICE ARE ADULTERATED AND MISBRANDED. FURTHERMORE UNDER 21 CFR 801.4 MANUFACTURE WAS REQUIRED, UPON KNOWLEDGE OF INTENDED USES OTHER THAN THOSE FOR APPROVED INDICATIONS, BEING INTRODUCED INTO INTERSTATE COMMERCE, MUST PROVIDE ADEQUATE LABELING. IN THE ABSENCE OF ADEQUATE LABELING, THE DEVICE(S) ARE MISBRANDED. PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS INCLUDING, BUT NOT LIMITED TO, LIPOMA, FLUID-FILLED CYST(S), ECTOPIC BONE GROWTH IMPINGING ON SPINAL NERVES AND LOSS OF BLADDER CONTROL. PATIENT HAD REVISION (B)(6) 2013 SURGERY TO REMOVE LIPOMA.