Catalog Number 55740005525 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog #: 55840005525, 510k #: k113174 and udi #: (b)(4) was cleared in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2019, the patient underwent fusion at t4-iliac due to proximal junctional kyphosis (pjk).On an unknown date, post-op, the screw on the left of t7 deviated to lateral side and located near the aorta.Posterior junction kyphosis infection was also reported.It was unknown if the infection was related to the implanted device or not.A revision surgery was performed on (b)(6) 2019, in which the deviated screw was removed.The patient has been placed under follow-up observation.
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Manufacturer Narrative
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X-ray results received: axial ct image from thoracic instrumentation was provided.Left t6-t7 described as having lateral screw placement.It is unclear which level this ct is for.This placement is a surgeon error.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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