Model Number NONE |
Device Problems
Bent (1059); Device Damaged by Another Device (2915); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in an l3-s1 posterior fusion spine procedure, the site's tactile awl was damaged using sacroiliac screws.When placing the 9.5x90 screw on the patient's left side, the straight tactile awl was bent.The surgeon also tapped line to line with a 9.5 tap.X-ray was used to confirm the screw was placed accurately.There was no impact on patient outcome.
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Manufacturer Narrative
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Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested.Replacement tactile awl shipped to site (b)(4) 2014.No parts have been returned to manufacturer for analysis.
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Manufacturer Narrative
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Although a specific cause of the reported incident was unconfirmed as the part was not returned to the manufacturer, further review of the complaint history by hardware engineering found additional occurrences of the reported issue.The reported physical damage is general and typical of the intended use.The complaints are being monitored through post market monitoring with no further actions required.
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Manufacturer Narrative
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Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.
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Search Alerts/Recalls
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