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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SHORT SPINOUS PROCESS CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC SHORT SPINOUS PROCESS CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734716
Device Problems Material Integrity Problem (2978); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
The clamp has been requested for return. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used during a spinal procedure. It was reported that the site was having issues with the drill stop not staying in the grooves of the drill bit and that it was loose. It was also noted that the spinous process clamp's washer or nut came out from the clamp when using the driver, and the site was not able to unscrew the clamp from the patient. The site was able to get the clamp off of the patient and no metal was found in the patient. There was no patient harm and the procedure was not delayed.
 
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Brand NameSHORT SPINOUS PROCESS CLAMP
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 Key10010307
MDR Text Key189363976
Report Number1723170-2020-01330
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
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734716
Device Catalogue Number9734716
Device Lot Number151002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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