CHOICESPINE, LLC CHOICESPINE LUMBAR SPACER SYSTEM (HARPOON); HARPOON PLI, SPACER PLI,25X10,0 DEG
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Model Number PP40-25120 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Unspecified Musculoskeletal problem (4535)
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Event Date 08/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The cause of the expulsion is inconclusive however one factor leading to device expulsion appears to be patient non-compliance during recovery.Appropriate physical exertion following surgery is patient dependent and it is acknowledged that there is limited control in this area.The implant is designed to engage the endplates and provide resistance to migration when appropriately placed and sized.Therefore, another possible contributing factor to device expulsion could be that the implant was under sized to the shape and size of the disc space.
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Event Description
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We had a female patient who had complained of either back pain, leg pain or weakness and had to be taken to the or to remove harpoon cage that have migrated out of the disc space.We did not place a new cage in any of the empty disc space where the the cages had backed out.During the original surgery, each cage was verified to be in optimal position by x-ray.(b)(6) can give you x-rays as needed.
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