Catalog Number 8734-5130 |
Device Problems
Crack (1135); Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2017 |
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 the blade of an assembly cracked, which allowed the shim to disassemble from the blade assembly during surgery.The blade and shim were removed from the wound.The blade assembly was not needed to complete the rest of 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 blade assembly was evaluated.The blade was found to have cracked, which allowed the shim to disassemble from the blade.The cause is likely attributed to impaction forces placed on the device while attempting to insert the shim into the disc space.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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