The patient underwent an optilif endo interbody fusion procedure via a tlif approach on (b)(6) 2023 at the l5/s1 level.Following the discectomy, a defect in the annulus was identified.The procedure continued with placement of an optimesh device.The surgeon opted to inspect the construct via anterior access due to concern of the annular defect.During this inspection, a laceration to the iliac vein was observed and successfully repaired.The patient currently has no clinical issues or complications.
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The information contained in this report is being provided to the fda to comply with medical device reporting regulations and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination of admission that a device has malfunctioned or that a device is related to an injury or death.Section d4: it is unknown which optimesh system device, if any, caused or contributed to the adverse event.
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