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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734716
Device Problem Mechanical Problem (1384)
Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative
The reported issue was evaluated by a cross-department team at medtronic. Excess torque can force the washer to dislodge. Once the washer is dislodged, the clamp screw can be fully disengaged from the instrument. If the washer is disengaged, but the clamp screw is threaded into the instrument, the clamp screw will function for spine clamp application to the spinous process, but the lack of a washer will prevent the clamp from opening. Based on the results of the tests, it can be concluded that the root cause of the failure occurs when the spine clamp¿s drive mechanism is opened to the design travel limits, and then the clamp screw is further torqued in an attempt to open beyond the travel limits and a torque of greater than or equal to 2. 72 nm is applied.
 
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation. Part not returned for analysis.
 
Event Description
A medtronic representative reported that, while in a spinal fusion, the spine clamp could not be removed from the spinous process of the patient. To remove the clamp, the portion of the spinous process was removed. It was noted that the surgeon experienced difficulties opening and closing the clamp prior to initial placement on the spinous process. The representative recommend the surgeon use a different clamp, but the surgeon elected to use the clamp. There was a reported delay to the procedure of less than 1 hour due to this issue. No additional information was provided.
 
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Brand NameCLAMP, SPINOUS PROCESS SHORT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key6748487
MDR Text Key102482331
Report Number1723170-2017-03100
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physical Therapist
Device Catalogue Number9734716
Device Lot Number160707
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/27/2017 Patient Sequence Number: 1
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