MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ARTIC-L¿ AND ARTIC-XL¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	5330009
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976); Mechanics Altered (2984)
Health Effect - Clinical Codes	Paralysis (1997); Spinal Cord Injury (2432)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Paralysis and dural injury.Product qty-2 with same lot#.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding an inserter and cage used for spinal surgery.Pre-op diagnosis was lumbar hernia.Procedure performed in the event was tlif.Levels implanted was l1/2.It was reported that intra-operatively, when the arctic-l was inserted, the cage rotated at the intervertebral foramina.There is a possibility that the dura injury occurred during that time.After the surgery, the patient suffered from paralysis in the right lower limb.There was a delay of less than 60 minutes.The cage (8*25 mm) was installed on the reported inserter, but when attempted to insert into intervertebral space, the angle of the cage changed.The intervertebral foramina had osteopetrosis.Therefore, after scraping the outer bone, the cage was re-installed on the same inserter and inserted again.Before inserting the cage, the trail was not used/tried; and a rotate distractor of 8 mm was implemented.When installing the cage to the inserter, it was installed straightly according to the procedure manual, and tightened the thumb wheel more, and was properly installed.The paralysis on the patient predicted post-operatively, but it was unclear.No problem was observed on the cage, and it has been implanted into the patient.Some treatment was given for the dural damage.The surgeon said that inserters might have deformed.The inserters were related to the patient¿s paralysis because the cage was unlocked at an unintended timing by the operator at the time of insertion.Surgeon claimed that the defect on inserters triggered the dural damage.The dural damage seemingly caused the paralysis.
Additional Manufacturer Narrative
Additional information: d9, h3, h6.H3: product analysis: product# 5330009 lot # id19k009 visual inspection did not reveal any damage to the threads or the shaft of the inserter.Functional check confirmed the inserter was able to be loaded and locked into the articulating shaft without any issues.The inserter appears to function as intended.No fault 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.
Additional Manufacturer Narrative
Correction : h6 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ARTIC-L¿ AND ARTIC-XL¿ SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13862242
• Report Number: 1030489-2022-00277
• Device Sequence Number: 20006428
• Product Code: MAX
• UDI-Device Identifier: 00643169762077
• UDI-Public: 00643169762077
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

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: 5330009
• Device Catalogue Number: 5330009
• Device Lot Number: ID19K009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 04/23/2024
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/18/2022; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male