Catalog Number 48230000 |
Device Problems
Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problem
Injury (2348)
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Event Date 10/21/2019 |
Event Type
Injury
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Event Description
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It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the migrated blocker.
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Event Description
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It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the migrated blocker.
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Manufacturer Narrative
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Visual inspection: there were no rod indentations on the bottom of the blocker indicating that the blocker was under-tightened.Functional inspection: the blocker was able to be threaded into a test screw.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.From the xia 3 surgical technique once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Examination of the blocker found that there were no rod indentations on the bottom of the blocker, which would be expected for a blocker tightened to 12nm.This indicates that the blocker was under-tightened and most likely the reason why it migrated or loosened out of the tulip.
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Search Alerts/Recalls
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