STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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Model Number 48950096 |
Device Problems
Fracture (1260); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 02/23/2018 |
Event Type
Injury
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Event Description
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A patient who was implanted with a cage in (b)(6), reported pain after the operation.It was further reported that the patient could not walk at all, a "black shadow like a foreign object" response was seen on ct images, symptoms improved as a result of block injections on the intervertebral disc and that "the intervertebral discs are doing bad things".The cage was removed on (b)(6) during a revision surgery.It was observed that the case did not fuse.After palpating the affected area, after removal, there was no cavity and normal.
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Manufacturer Narrative
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Upon follow up it was reported that patient's pain disappeared and the patient could walk.The patient's pre-operative diagnosis was spinal canal stenosis.The reported event was confirmed via correspondence and visual inspection of the explanted cage.Materials analysis performed concludes that the cage fractured in ductile overload.The fracture origins were located along the outer surface and consistent with an overload condition.No materials or manufacturing defects were observed.The type of overload and the likely root cause could not be determined from the information provided.
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Event Description
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A patient who was implanted with a cage in june, reported pain after the operation.It was further reported that the patient could not walk at all, a "black shadow like a foreign object" response was seen on ct images, symptoms improved as a result of block injections on the intervertebral disc and that "the intervertebral discs are doing bad things".The cage was removed on february 23 during a revision surgery.It was observed that the case did not fuse.After palpating the affected area, after removal, there was no cavity and normal.
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