MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7´; INSTRUMENT, STEREOTAXIC

Model Number	9733857
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.It was reported that there was no failure found with the system.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.Other relevant device(s) are: software 9733686 s7 synergy spine, version (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that after a sacroiliac and thoracolumbar procedure it was discovered that a screw had allegedly been misplaced.A wake-up test was performed and the patient was said to have lost sensation in her legs.There was no delay to the procedure reported.
Additional Manufacturer Narrative
Additional information: patient dob updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the screws were revised on the same date as the reported event was observed.
Additional Manufacturer Narrative
A software investigation was initiated.Unable to determine probable cause without further information since the behavior cannot be replicated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received: the patient was still experiencing paralysis of lower limbs post-operatively following the event.The amount of inaccuracy was unknown, it was stated that they were too medial with the screws. the screw misplacement was observed after all screws went in and the site took a confirmation spin.  the initial indicator was the motor testing was unresponsive.The misplaced screws were not revised during the event.It was unknown if the screws were revised at a later date.The images were taken before the case for navigation purposes, immediately following discovery of potential issue.

• Brand Name: STEALTHSTATION® S7´
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; navigation customer quality; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9190183
• Report Number: 1723170-2019-05215
• Device Sequence Number: 2600165
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 12/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/14/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Weight: 41