Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Information (3190)
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Event Date 07/08/2016 |
Event Type
Injury
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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.Report two of four for the same event; see also 0002184052-2016-00150, 00152 and 00153.
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Event Description
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The sales associate reported non-functional instruments.During a case the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly, therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous, because the short sleeves were not long enough for the obese patient, to a mini open type approach.
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Manufacturer Narrative
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The returned lock pins were examined.There were no signs of visual deformities or discrepancies.They were functionally checked with mating extender sleeves and pedicle screws ,and were found to function properly.A review of the manufacturing records did not identify any issues that would have contributed to this event.No product failures were detected; the complaint could not be confirmed.
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Manufacturer Narrative
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Review of this file found that this device was incorrectly reported.There was not an allegation of malfunction associated with this device and subsequent device evaluation did not find any device malfunctions.
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Search Alerts/Recalls
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