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

Model Number 9734716

Device Problem Mechanics Altered (2984)

Patient Problem Iatrogenic Source (2498)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

The clamp has been requested for product analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a spinal procedure.It was reported that there was an issue while using the short single spine clamp.The screw would not engage, so the clamp would not close.The surgeon had to use a compressor and drill off cortical bone in order for the clamp to work.There was no patient harm and the procedure was not delayed over an hour.

Manufacturer Narrative

H2) additional information: see b5.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.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.

Event Description

Medtronic received additional information that there was no damage.It was reported that the clamp was designed to not engage if opened too wide.

• Brand Name: SHORT SPINOUS PROCESS CLAMP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10125109
• MDR Text Key: 194205911
• Report Number: 1723170-2020-01604
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 82