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Catalog Number 283910000 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Code Available (3191)
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Event Date 04/28/2014 |
Event Type
malfunction
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Event Description
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International affiliate reports that once the cement was mixed, the purple injection device (ie.The confidence kit pump) failed to attach to the full cement container (the kit¿s cement reservoir) through the quick-lock mechanism despite there having been no modification to the integrity of the device by the surgeon or scrub staff.This occurred with two devices from separate confidence kits with the same batch number.When a third kit with a different batch number was opened, there was no problem.The difficulties resulted in a delay of forty five minutes to the procedure.The following mfg.Medwatch reports are being filed for the two confidence kits that were involved in this event: 1526439-2014-11514; 1526439-2014-11515.
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Manufacturer Narrative
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Additional narrative: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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The confidence spinal 11cc cement system was not available for evaluation.A review of the device history records (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A 12 month review of the complaint trend analysis for the confidence system was conducted on the product family as this fault could occur across the entire confidence product line.This analysis found no emerging trends.No corrective action/preventive action (capa) is necessary at this time as we are unable to confirm the reported issue or identify the root cause.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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