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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SPINOUS PROCESS CLAMP TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SPINOUS PROCESS CLAMP TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735249K
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.No parts have been returned to the manufacturer for analysis.Device manufacture date is not available at time of filing.
 
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that an orthopedic stereotactic instrument was broken.There was no patient present when this issue was identified.
 
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Brand Name
SPINOUS PROCESS CLAMP TALL
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7569447
Report Number1723170-2018-02519
Device Sequence Number16440830
Product Code OLO
UDI-Device Identifier00643169936317
UDI-Public00643169936317
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 06/05/2018
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 Health Professional
Device Catalogue Number9735249K
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2018
Initial Report FDA Received Date06/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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