Catalog Number 8219500 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Procode: owi: bone fixation cerclage, sublaminar.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent scoliotic curve correction after she was diagnosed with scoliosis.Intra-op, when the surgeon performed a huge traction with clamps with the aim of re-aligning the anterio-posterior curve, the tethers got damaged in correspondence to the tensioner.The distal part of the tether was cut as indicated in the surgical technique.Derotation was applied using gripper and applying tension to the clamp.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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Product analysis: visual and optical inspection revealed the tether was returned into 2 pieces.A visual review of the failure points shares a consistent physical appearance.The tether appears to have been cut straight across.This type of damage is consistent with a the tether coming in contact with a sharp edge or cutting blade.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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