MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL; INSTRUMENT, STEREOTAXIC

Model Number 9734056

Device Problems Imprecision (1307); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9730864, serial/lot #: (b)(4), ubd: unknown, udi#: (b)(4).Product id: 9730864, serial/lot #: (b)(4), ubd: unknown, udi#: (b)(4).This event took place in (b)(6).No products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during an oblique lumbar interbody fusion (olif) procedure.It was reported that the joint that fixes the iliac frame cannot be fixed.It became loose.An inaccuracy of 1cm or more occurred.The site aborted navigation and continued with the procedure.This issue occurred during navigation.Auto-registration had been used.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.Additional information received from a manufacturer representative reported that the was considered to be deterioration due to aging.The issue was resolved by replacing the fixators.The inaccuracy was 2cm.Additional information was received.It was reported that this issue occurred with two separate fixators.

Manufacturer Narrative

Concomitant products information references the main component of the system.Other relevant device(s) are: product id: 9730864, lot/serial #: (b)(6).The fixator was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.Both returned fixators are well worn but otherwise intact and fully functional.No problem found.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.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11557990
• MDR Text Key: 242309190
• Report Number: 1723170-2021-00769
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1