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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9731780
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
 
Event Description
A medtronic representative reported that while outside of procedure, the allen driver slot of the spine clamp was damaged.There was no patient present at the time of the issue.
 
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Brand Name
OPEN SPINE CLAMP, TITANIUM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
prashanth gali
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7123180
MDR Text Key95070952
Report Number1723170-2017-05110
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K990214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number9731780
Device Lot Number110330
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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