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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734716 SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC CLAMP 9734716 SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734716
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the spine clamp was damaged.The washer sheared off.
 
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Brand Name
CLAMP 9734716 SPINOUS PROCESS SHORT
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8565344
Report Number1723170-2019-02049
Device Sequence Number11279070
Product Code OLO
UDI-Device Identifier00643169936294
UDI-Public00643169936294
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
PMA/510(K) Number
K131425
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/30/2019
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 No Information
Device Model Number9734716
Device Catalogue Number9734716
Device Lot Number160318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2019
Initial Report FDA Received Date04/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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