MAUDE Adverse Event Report: WARSAW ORTHOPEDICS LONGITUDE II; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 1555106100

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

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient for an unknown spinal therapy.It was reported that revision surgery was scheduled for (b)(6).There was patient involved in the event and no further complications reported regarding the event.Additional information was reported on (b)(6) 2020: patient demographics: last name: (b)(6), first name: (b)(6), male, (b)(6).The reoperation scheduled on (b)(6) 2020 has been performed.The reason for reoperation is ossification of posterior longitudinal ligament.The degree of numbness or paralysis is unknown.Since stenosis occurred due to ossification of posterior longitudinal ligament, decompression fixation was performed between t8 and l1.There was no malfunction in the l2/3/4 implants that had already been implanted, and only the rod was removed and fixation was performed again from t8 to l4.No reports have been received so far regarding the health damage of patients after reoperation.The removed rod and set screw will be returned to the patient and will not be returned to medtronic.

Manufacturer Narrative

H3: device return was requested, however the device was not returned at the time this investigation was completed and no analysis could be performed.The investigation determined that the cause of the event was not related to the product, and therefore no further investigation was required.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.

Event Description

Additional information was reported on 2020-07-16: the product number is 1555106100 and lot number is 0374661w.

• Brand Name: LONGITUDE II
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw,in PR 46582
• MDR Report Key: 10269281
• MDR Text Key: 198708754
• Report Number: 1030489-2020-00892
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: 1555106100
• Device Catalogue Number: 1555106100
• Device Lot Number: 0374661W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR