MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV2002
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Spinal Cord Injury (2432); Unspecified Nervous System Problem (4426); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding spinal product that will be used in fusion spinal therapy for t9-t12 decompression.It was reported that the patient has motor and sensory issues in his leg.No further complications or symptoms were reported.Additional information was received via manufacturer representative that the blue handle became disengaged/malfunctioned from the awl tip tap causing the patient a spinal cord injury.The surgeon believes that the scrub tech never correctly attached the handle to the awl tip tap in which caused the instrument to slide off the handle when he introduced to the spine.There is no allegation of the purple nav lock as it was simply attached to the awl tip tap.Surgeon had 2 screws in before this incident using these same instruments with no issue.After the incident the scrub tech that is alleging the malfunction was given a break and was replaced by another scrub tech for the remainder of the case.We continued to use exactly the same instruments for 6 more screws with no issue.The reported patients injury is from the 4.5 awl tip tap with the purple nav lock attached striking the spinal cord when it slid off the blue handle.No revision surgery has been performed.The patient is still in the hospital and is going to start physical therapy.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6: e2402 - patient had disability.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received via manufacturer representative that the tap handle and shaft disengaged or were not fully engaged resulting in the instrument or shaft impacting the spinal cord at t11-t12 laminectomy site which caused to sustain serious injuries, including but not limited to severe loss of function in his lower extremities, severe pain and disability.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 17875279
• Report Number: 1030489-2023-00681
• Device Sequence Number: 4401166
• Product Code: OLO
• UDI-Device Identifier: 00643169347540
• UDI-Public: 00643169347540
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: NAV2002
• Device Catalogue Number: NAV2002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2023
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male