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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC.; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC.; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/25/2022
Event Type  malfunction  
Event Description
Patient scheduled for elective lumbar spinal fusion (as a same day admission).Surgeon used medtronic thoracic probe (hospital-owned instrument) to access spinal pedicle.While attempting to access pedicle, tip of probe (approx.35mm) broke off in patient in left s1 pedicle.Surgeon attempted to remove, but too difficult.A decision was made by the surgeon to proceed without removal of tip since it would cause significant disruption to the pedicle that would preclude screw placement.It was decided to leave the distal tip of the pedicle probe in the bone.Surgeon completed procedure, placed screw parallel to retained tip, and informed patient's wife of events.This probe is re-sterilized in house through cspd.
 
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Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek circle
ms ss-54
louisville CO 80027
MDR Report Key14753629
MDR Text Key294394755
Report Number14753629
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2022
Event Location Hospital
Date Report to Manufacturer06/21/2022
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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