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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 Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Patient sex unavailable at the time of filing d4) unique device identifier (udi) is unavailable. Device manufacture date is unavailable. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar. It was reported that during a clinical case, the site was having issues with the short spinous process clamp gauging on the patient. It was reported that there was a piece missing which wasn't allowing the clamp to tighten. There was a patient present at the time of event. Unknown delay in the case. On 2019-dec-21 (rep) new information received: no delay in case. Used the longer clamp. The short clamp wouldn¿t tighten because a component to the post was missing. It was noticed prior to the patient being in the room  after x2 screws were placed¿the surgeon bumped/hit the frame on the longer clamp throwing off the accuracy of navigation.  new image acquisition was offered but the surgeon chose to move on and go with out navigation for the other x2 screws.
 
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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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9529719
MDR Text Key184852519
Report Number1723170-2019-06205
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,Followup,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734716
Device Catalogue Number9734716
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
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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