STRYKER SPINE-US AERO AL FIXATION ANCHOR, 30MM, BLUE CARTRIDGE; INTERVERTEBRAL BODY FUSION DEVICE
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Catalog Number 48923000 |
Device Problems
Mechanical Problem (1384); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2015 |
Event Type
malfunction
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Event Description
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It was reported that; during an alif using aero al two of the anchors were impacted but did not engage bone, rather were inserted and ended up in the disc space between the cage and the end plate.This occurred at l5/s1 with the inferior anchors.Additionally at l3/l4 there was an issue with a blade folding like an accordion upon attempted insertion.During this procedure, two cages were implanted and explanted, two were finally implanted and fixated.Patient is fine after surgery there was not damage to the patient.30 minutes + delay for removal of the original implant that failed.
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Manufacturer Narrative
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Method: device evaluation, device history review and complaint history review could not be performed as no lot code was provided.Results: email correspondence with sales rep indicated the pilot cutter was not used on the anchors with which the problems were encountered and that the bone was harder than average.Therefore; these could have been contributing factors.Conclusion: the root cause of the reported event cannot be determined conclusively as no devices and insufficient information was received by stryker.
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Event Description
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It was reported that; during an alif using aero al two of the anchors were impacted but did not engage bone, rather were inserted and ended up in the disc space between the cage and the end plate.This occurred at l5/s1 with the inferior anchors.Additionally at l3/l4 there was an issue with a blade folding like an accordion upon attempted insertion.During this procedure, two cages were implanted and explanted, two were finally implanted and fixated.Patient is fine after surgery there was not damage to the patient.30 minutes + delay for removal of the original implant that failed.
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Search Alerts/Recalls
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