Catalog Number 3505-6540 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.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 screw disassembled during surgery.After final tightening, the surgeon decided to change the placement of the screw but upon removal, the screw's tulip head disassembled from the screw shaft.An alternative screw was used to complete the procedure.There were no reports of patient impacts associated with this event.
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Manufacturer Narrative
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The returned screw was evaluated.The tulip and swivel ring were confirmed to have disassembled from the screw shaft.The swivel ring was deformed in a manner consistent with tightening and later loosening of the mating closure top and rod within the tulip.This deformation allows the tulip and swivel ring to disassemble from the screw shaft as the screw is manipulated during removal or reuse.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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