Catalog Number 824M5545 |
Device Problem
Fracture (1260)
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Patient Problems
Pain (1994); Foreign Body In Patient (2687)
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Event Date 08/04/2022 |
Event Type
Injury
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Event Description
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It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report one of three for this event.
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2022-00204.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed that the tip of the screw was fractured off, and the tips of both cannulated taps were fractured.Potential cause: root cause was unable to be determined.This event could possibly be attributed to inserting the screw without tapping initially, or due to sclerotic bone.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report one of three for this event.
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Search Alerts/Recalls
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