SPINOUS PROCESS CLAMP 9734716

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for SPINOUS PROCESS CLAMP 9734716 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185252654] Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185252655] Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure. It was reported that the spinous process clamp moved. They were working on the last level, l5, and noticed that the clamp had moved. They checked their accuracy and decided to finish the case with a c-arm. Troubleshooting was done by the clinical specialist (cs) that was onsite and there were no issues with the clamp remaining engaged. It was believed that it was attached to soft tissue that allowed it to shift. There was a procedure delay of less than one hour and no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01092
MDR Report Key9889286
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPINOUS PROCESS CLAMP
Generic NameORTHOPEDIC STEREOTAXIC INSTRUMENT
Product CodeOLO
Date Received2020-03-27
Model Number9734716
Catalog Number9734716
Lot Number170425
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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