(b)(4) units of the bone cement lot 045a23071 have been sold individually between 02-mar-2023 and 18-apr-2023, this is the first claim received.Physico-chemical characteristics, functional characteristics and microbiological controls of the batch 045a23071 are compliant.
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The invictus spinal cement system 17095-s lot 060423095 is an assembly of 2 devices: - purekit t060425 lot 060423014 - invictus bone cement 17095-1-s lot 045a23071 surgeon intended to use invictus fenestrated system with invictus spinal cement system (17095-s) to augment fenestrated screws in lumbar spine to improve fixation strength in osteoporotic bone.Using visual information and a stopwatch, the speed of injection was faster than what is recommended per the ifu.Observations show an injection speed of approximately 1 revolution per 2 seconds, compared to the recommended 1 revolution per 4 seconds.Verbal instructions on injection speed were given to the surgeon from the sales representative and a development engineer prior to the start of cement injection, which was not followed.Approximately 10 minutes after injection of cement the patient experienced an embolism.After prompt response from the surgical team, the patient stabilized.
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