Catalog Number 41532907-S |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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While using a slap hammer to get the inserter out of the disc space, the proximal tantalum marker portion of the cage broke from the rest of the cage.The surgeon was able to retrieve the broken portion and remove it from the disc space.Then, the surgeon was able to position the rest of the cage properly in the disc space.This event is reportable as a malfunction.
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Event Description
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Surgeon was on the patients left at l3-4 using 7mm ti coated peek banana cage (41532907-s) // (lot = j4e8x-k406y) with the 15-degree angled inserter.No screws were placed yet.Implant was impacted into disc space and articulated properly.The wheel of the inserter was turned to disengage the implant from the inserter and a slap hammer was used to get the inserter out of the disc space.While slap hammering, the proximal tantalum marker portion of the cage came out with the inserter, still slightly engaged to inserter.The broken piece was retrieved and removed from the field.The rest of the implant was placed properly in the disc space.
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Manufacturer Narrative
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While using a slap hammer to get the inserter out of the disc space, the proximal tantalum marker portion of the cage broke from the rest of the cage.The surgeon was able to retrieve the broken portion and remove it from the disc space.Then, the surgeon was able to position the rest of the cage properly in the disc space.This event is reportable as a malfunction.(b)(6) 2024- it would appear that angulation is exerted when the patient's anatomy is complicated as well as when using the product with a minimally invasive technique.This brings us to the limits of the tlif tivac system.This procedure is, however, not described in the surgical technique.
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Event Description
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Surgeon was on the patients left at l3-4 using 7mm ti coated peek banana cage (41532907-s) // (lot = j4e8x-k406y) with the 15-degree angled inserter.No screws were placed yet.Implant was impacted into disc space and articulated properly.The wheel of the inserter was turned to disengage the implant from the inserter and a slap hammer was used to get the inserter out of the disc space.While slap hammering, the proximal tantalum marker portion of the cage came out with the inserter, still slightly engaged to inserter.The broken piece was retrieved and removed from the field.The rest of the implant was placed properly in the disc space.
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Search Alerts/Recalls
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