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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERC PIN ADAPTER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC PERC PIN ADAPTER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734752
Device Problem Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
Device lot number, or serial number, unavailable. No devices were returned to the manufacturer for analysis. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that intra-operatively, the site had issues with the perc pin. While seated inside of the perc pin adapter, the site noted that there was movement which forced them to re-direct two screws after placement as the perc pin caused inaccuracy. An additional 3d confirmation spin was needed to complete the case. There was no reported impact to patient outcome. There was reported delay to the procedure of 15-20 minutes due to this issue.
 
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Brand NamePERC PIN ADAPTER
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 Key8203437
MDR Text Key131635032
Report Number1723170-2018-06498
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 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734752
Device Catalogue Number9734752
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 Received12/04/2018
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 Reuse

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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