Model Number NONE |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/03/2015 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that during a spinal fusion procedure the surgeon was using a tap instrument when it was removed from the anatomy it was discovered to be bent.The site switched to another tap and 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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Replacement device shipped to site on 06/04/2015.Medtronic investigation of returned suspect device finds that as reported, the tip of the instrument is visibly bent.Otherwise, there are minor impact marks at the back end of the instrument.The reported event was confirmed to be caused by the physical damage of the instrument tip.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation 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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