Model Number 482804645 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Injury (2348)
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Event Date 06/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Hospital discarded device.
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Event Description
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A surgeon reported that a patient may have experienced metallosis at the l4 level whilst implanted with two es2 screws and two es2 hex rods.The patient was undergoing a scheduled revision surgery to extend the construct to s1 when the surgeon noted, "metallosis around the l4 screws," and, "some evidence of discolouration of the surrounding tissue adjacent to the screws." surgery was completed as planned; the rods were explanted and replaced with longer rods and the l4 screws were replaced.This report represents the second of the two screws.
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Manufacturer Narrative
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Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.An exact root cause of the reported event could not be determined.Potential causes from risk table include: - surgeon damaged surrounding soft tissue.- implant irritates soft tissue.- incorrect implant size selected.- patient pathology.
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Event Description
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A surgeon reported that a patient may have experienced metallosis at the l4 level whilst implanted with two es2 screws and two es2 hex rods.The patient was undergoing a scheduled revision surgery to extend the construct to s1 when the surgeon noted, "metallosis around the l4 screws," and, "some evidence of discolouration of the surrounding tissue adjacent to the screws." surgery was completed as planned; the rods were explanted and replaced with longer rods and the l4 screws were replaced.This report represents the second of the two screws.
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Search Alerts/Recalls
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