Catalog Number 7578302 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review: submitted images appear to display damaged instrument.
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Event Description
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Pre-operative diagnosis: l3/4/5: spondylolisthesis procedure: extreme lateral interbody fusion (xlif) surgery at l3/4/5 and posterior fusion was performed with percutaneous pedicle screw levels implanted: l3-5 it was reported that during surgery, the extender could not be removed from screw head.While trying to remove it, the tip of the extender broke.No fragments of the product remained in the patient.No patient complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Visual examination identified associated -04/-05 component head grippers are bent laterally and fractured and at the corners of the notch.Visually and optically identified witness marks and deformation on the inside of head grippers, suggesting possible inappropriate instrument release technique.The above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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