Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
Procedure-l4-l5 fusion implant date: (b)(6) 2009 (year valid) it was reported that: in late 2009: the patient underwent spinal fusion surgery with bone abrasion from l4-l5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "the patient began to suffer from severe pain in her lower back and legs following the surgery".In 2010: the patient underwent same spinal fusion with bone abrasion from l4-l5 that had been previously performed as 'the bone was growing back".Allegedly, "the patient continued to suffer from increased pain in legs and lower back following the second surgery." in 2011: the patient underwent cervical spinal fusion and the installation of a spacer as the result of degenerative disc disease.In (b)(6) 2012: the patient underwent same spinal fusion with bone abrasion from l4-l5 that had been performed twice.Allegedly, "the patient was unable to lift her legs the way she previously could, and trip easily over even slightly uneven surfaces.Additionally, she suffers from continuous pain in her neck, causing migraines; as well as from pain in her legs and lower back.".
|