MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC GUIDEWIRES; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 8670001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of lumbar spondylolis thesis involved in olif+pps procedure used in spinal therapy.Levels implanted: l4/5.It was reported during use, superior adjacent segment disease in patient was reported.There was no malfunction of the product reported.The bone was fragile originally because of steroids, rheumatism or dialysis.Removal of rod and set screw was planned on (b)(6) 2020.There was no plan to remove cage in revision surgery.Quantity-2 screws were removed on l5, but lot# is unknown.There was no malfunction of implanted products.Olif was performed on l4/5, posterior sentant was performed.Due to adjacent segment disease on l3/4, it was planned to perform olif on l3/4 and insert pps in l3 and perform connection on l3-5 on (b)(6).Additional information regarding the re-operation: bone fusion was achieved completely on l4/5, screw on l5 was removed.Olif was performed between l3/4, posterior fusion on l3/4 with pps was performed and the operation was completed.Patient status is unknown, but movement of leg right after the operation was well.

Event Description

Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

Manufacturer Narrative

H1: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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: GUIDEWIRES
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10733721
• MDR Text Key: 213003690
• Report Number: 1030489-2020-01483
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00721902293115
• UDI-Public: 00721902293115
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8670001
• Device Catalogue Number: 8670001
• Device Lot Number: KH14B246
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention