MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 54750016545

Device Problems Break (1069); Misassembly by Users (3133)

Patient Problem Thrombosis (2100)

Event Date 10/02/2019

Event Type  Death  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.Although it is unknown whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.H10: hcp review results: this event is related to the surgery and has no cause-effect relationship with the device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent percutaneous pedicle screw fixation at posterior side of t11-l5 due to l2 vertebral body fracture from a tumble.Intra-op, the set screw on the left side of l3 did not engage with the screw even though it was pushed.Although the set screw was caught on, it idled during tightening.The tab extender cap had been attached, but the tab of the screw broke; so, the surgeon tried skin incision but the set screw did not engage.The screw was explanted and a bigger set screw was inserted again.There was a gap noted between the rod and the screw head as well.The procedure was delayed by less than 60 minutes due to this event.Post-op, after final tightening and wound closure was done without problems, when patient's position was changed to supine position, patient's condition had a sudden deterioration and the nurse reported the color of patient's feet was not good.The condition turned to a cardiac arrest state and treatment was performed at the operation room for more than an hour.The reason suspected for health deterioration was reported that when setting position, although vertebral body reduction had been performed, it was felt that the anterior side of the vertebral body opened during the operation.According to the doctor, this occurred maybe because the pillow placed at the abdomen displaced during the operation, and the unintended part was pressed due to the displacement.The patient was then transferred to icu in the state that "vf" still did not return.Then, at a later date, on (b)(6) 2019, it was heard that the patient had died.The cause of death was reported as pulmonary thrombosis.The doctor reported that the death was attributable to the release from the compression of groin; and not related to the malfunction of the implant.When checking the screw, some scratches were noted on a part of the tab threads while the threads of the screw appear to have no problem.

Manufacturer Narrative

H6: product analysis: visual and optical inspection revealed the screw was returned with the break off tabs removed.The tabs appear to have been removed correctly.The female torx has been worn from possible interface from the driver head.The threads of the saddle of the screw appear to be undamaged.Functional check with sample set screw confirmed the screw was able to thread into the saddle with out any issues.The screw 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.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9264987
• MDR Text Key: 164573170
• Report Number: 1030489-2019-01237
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169501065
• UDI-Public: 00643169501065
• Combination Product (y/n): N
• PMA/PMN Number: K143375
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54750016545
• Device Lot Number: H5395353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SET SCREW, ROD; SET SCREW, ROD
• Patient Outcome(s): Death