Model Number 1119.0010 |
Device Problems
Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Weakness (2145)
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Event Date 11/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Neither the device or any imaging could be provided.No determinations could be made.
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Event Description
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It was reported that a revision surgery was done to revise a construct from t10 to l1 due to locking caps disengaging from the screw heads, a screw backing out at l1, and 2 rods disengaging from the screws at t10-t12 post-operatively, causing patient pain and leg weakness.
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Manufacturer Narrative
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The observed markings on the implants indicate that the implants had loosened from the rod.Possible causes include varying tightening conditions from rod angle, rod bend, reduction, insufficient tightening, or excessive loading.The exact cause of the reported issue could not be determined.
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Event Description
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It was reported that a revision surgery was done to revise a construct from t10 to l1 due to locking caps disengaging from the screw heads, a screw backing out at l1, and 2 rods disengaging from the screws at t10-t12 post-operatively, causing patient pain and leg weakness.
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Search Alerts/Recalls
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