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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734715 SPINOUS PROCESS TALL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC CLAMP 9734715 SPINOUS PROCESS TALL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734715
Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)
Patient Problem Spinal Column Injury (2081)
Event Date 09/21/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). The spinous clamp was not returned to the manufacturer; therefore there was no evaluation conducted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a cervical spine procedure. The issue occurred intraoperatively and delayed the surgery by 20 minutes. It was reported that the site was going to do a posterior cervical fusion c1-c3. They put the long spinous process clamp on c2 but couldn't get the clamp to close, the surgeon had to remove bone in order to get the clamp to close. The surgeon tried to get the clamp tightened which ended up crushing the spinous process then it broke off. The surgeon tried the same thing on c3 and he removed bone to get it to tighten but then he tightened it and it crushed the spinous process then broke off. The surgeon used a second long spinous process clamp but couldn't get any purchase on it. The manufacturer representative (mr) then tried locating a 3rd spinous process clamp to try but the time he got back, the site ended up aborting navigation. The mr looked at both clamps and they appeared to function as expected.
 
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Brand NameCLAMP 9734715 SPINOUS PROCESS TALL
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 Key7908075
MDR Text Key121700662
Report Number1723170-2018-04919
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 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734715
Device Catalogue Number9734715
Device Lot Number170425
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 Received09/21/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/25/2018 Patient Sequence Number: 1
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