Catalog Number 9734679 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Patient age not made available from the site.Return requested.No parts have been received by manufacturer for analysis.No further issues have been reported.
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Event Description
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A medtronic representative reported that, while in a spine procedure, the surgeon bent the tip of their lumbar probe.The surgeon continued the procedure using a straight gear ship instrument.There was no delay in the procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Suspect probe was returned for evaluation: as reported, the tip of the probe is twisted.Also, there are several impact marks at the back end of the instrument.Physical damage: bent instrument tip.This issue will be trended and monitored in a medtronic hardware anomaly tracking database.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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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 its 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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