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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 Problem Material Integrity Problem (2978)
Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)
Event Date 09/18/2019
Event Type  Injury  
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 for a sacroiliac and thoracolumbar procedure. It was reported that too much force was applied with the spine clamp and the t handle causing the surgeon to damage a spinous process. He stated he was unable to feel what force he was applying. There was no other procedural information provided.
 
Manufacturer Narrative
Additional information received from a manufacturer representative reported that the surgery was delayed by five minutes and the spinous process was fractured. 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 sacroiliac and thoracolumbar procedure. It was reported that the surgeon fractured a spinous process by applying too much force with the t handle. The surgeon stated that they were unable to feel what force they were applying. There was a delay of five minutes.
 
Manufacturer Narrative
Additional information received from the manufacturer representative provided the gender of the patient and the lot number of the clamp. If information is provided in the future, a supplemental report will be issued.
 
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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 Key9210387
MDR Text Key163050528
Report Number1723170-2019-05282
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734715
Device Catalogue Number9734715
Device Lot Number180409, 181019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2018
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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