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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SPINOUS PROCESS CLAMP TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC SPINOUS PROCESS CLAMP TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734715
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system instrument being used intra-operatively of a sacroiliac and thoracolumbar procedure.It was reported that they were unable to remove the clamp and reference frame from the spinous process as the screws or the portion to remove the system were damaged and fell out.They were able to get the clamp off the patient and metal removed.There was a 5 min delay noted.There was no impact on the patient outcome.
 
Event Description
Additional information was provided stating that the likely cause of damage is heavy utilization of the instrument and the instrument's age.
 
Manufacturer Narrative
B5: additional information medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SPINOUS PROCESS CLAMP TALL
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key10454965
MDR Text Key204874545
Report Number1723170-2020-02279
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/06/2020
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
Device Operator No Information
Device Model Number9734715
Device Catalogue Number9734715
Device Lot Number15111
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received08/26/2020
Supplement Dates Manufacturer Received09/15/2020
Supplement Dates FDA Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight104
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