Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/06/2016 |
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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The sales associate reported a broken instrument.During a posterior cervical fusion procedure the tower reducer was noticed as broken.The surgery was completed.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.(b)(4).
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Manufacturer Narrative
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The returned device was examined.One of the tabs has broken off the distal tip.The complaint is confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.The damage is consistent with off-axis forces placed on the device during usage.If additional, relevant information becomes available, a supplemental report will be filed.
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Search Alerts/Recalls
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