Catalog Number 07.02050.206 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
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Event Description
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It was reported that a pedicle screw disassembled while being removed immediately after installation during surgery.The screw was removed and replaced with an alternative screw without reported patient impacts.
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Manufacturer Narrative
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Additional information: the iliac screw was not returned; however a photo of the device was provided and used for evaluation purposes.The tulip head was confirmed to be disassembled from the screw shank.The cause of this failure cannot be conclusively determined without evaluation of the complaint part.However, the disassembly was likely caused by removal of the fully implanted screw.Since the lot number is unknown, the dhr was unable to be reviewed.
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Search Alerts/Recalls
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