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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
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
No parts have been returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used sacroiliac and thoracolumbar procedure. It was reported that the site was having issues with engaging the spinous process clamps during a procedure. The representative was able to walk the surgeon through the process by using another clamp, same model and they were able to continue in the case. This was their second time using these instruments. There was no reported delay and no reported impact to patient outcome.
 
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Brand NameCLAMP 9734716 SPINOUS PROCESS SHORT
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10356151
MDR Text Key201542249
Report Number1723170-2020-02089
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 08/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734716
Device Catalogue Number9734716
Device Lot Number191104
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 Received07/30/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/04/2019
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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