Model Number 48233540 |
Device Problems
Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Status and location of the device is unknown.
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Event Description
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It was reported that the tulips of nine xia deformity uniplanar screws "released" post-operatively.Revision surgery has been performed.This report will capture the third of nine screws.
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Manufacturer Narrative
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B5 was updated to reflect the additional information received'.After evaluating x-ray provided, it is noted that not all 9 tulips disengaged as previously reported.Seven of the nine screws have no issue and were not returned.Tulip disengagement can be seen on x-ray in 2 screws and are captured in mfr report #0009617544-2021-00025 and 0009617544-2021-00032.There was no alleged issue with this screw.
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Event Description
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It was initially reported that the tulips of nine xia deformity uniplanar screws "released" post-operatively.However, upon additional information received, it was confirmed that this only happened to 2 screw tulips.Revision surgery was performed where the two screws were explanted.There was no alleged issue with this screw.
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Search Alerts/Recalls
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