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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 2.25MM PEDICLE PROBE; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC 2.25MM PEDICLE PROBE; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733457
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pedicle probe was returned to medtronic for evaluation.It was determined that there was a physical damage failure with the pedicle probe.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported that 2.25 pedicle probe was damaged.It was noted that the damage occurred in reprocessing.There was no patient present.
 
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Brand Name
2.25MM PEDICLE PROBE
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8817622
Report Number1723170-2019-04189
Device Sequence Number3206118
Product Code HAW
UDI-Device Identifier00613994335968
UDI-Public00613994335968
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K050438
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number9733457
Device Catalogue Number9733457
Device Lot Number140403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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