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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734716
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/05/2018
Type of Reportable Event Malfunction
Additional 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 analysis.
 
Event or Problem Description
A medtronic representative reported that, while outside of a procedure, the spine clamp could not be tightened sufficiently.There was no patient present when this issue was identified.No additional information was provided.
 
Additional Manufacturer Narrative
The clamp was returned to the manufacturer for analysis.The clamp was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
 
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Brand Name
CLAMP, SPINOUS PROCESS SHORT
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7370753
Report Number1723170-2018-01316
Device Sequence Number13464877
Product Code OLO
UDI-Device Identifier00643169936294
UDI-Public00643169936294
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date (Section B) 08/24/2018
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
Operator of Device Physician
Device Catalogue Number9734716
Device Lot Number170905
Initial Date Received by Manufacturer 03/05/2018
Supplement Date Received by Manufacturer08/02/2018
Initial Report FDA Received Date03/26/2018
Supplement Report FDA Received Date08/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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