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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734716
Device Problem Material Integrity Problem (2978)
Patient Problem Tissue Damage (2104)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
Patient age not available. Device has not been returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure. It was reported the short spinous process clamp would not disengage from the spinous process. The site had to shave the anatomy and slide the clamp off. This issue occurred intraoperatively and caused a less than one-hour surgical delay.
 
Manufacturer Narrative
The short spinous process clamp was returned to the manufacturer for analysis. Analysis found that the retainer ring had been pulled from the tip pf the adjustment screw and was missing. The clamp was able to close but not open. Analysis found that the reported event was related to a mechanical issue. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8331805
MDR Text Key136127712
Report Number1723170-2019-00623
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734716
Device Catalogue Number9734716
Device Lot Number160317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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