MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCRW_SXT

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: please note that this date is based off of the date of acceptance.Weerasak singhatanadgige, phattareeya pholprajug, kittisak songthong, wicharn yingsakmongkol, chanonta triganjananun, vit kotheeranurak and worawat limthongkul comparative radiographic analyses and clinical outcomes between o-arm navigated and fluoroscopic-guided minimally invasive transforaminal lumbar interbody fusion.Int j spine surg 2022, 16 (1) 151-158 , doi: https://doi.Org/10.14444/8183 d6a.The date range for surgical procedures is january 2016 to december 2018.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.

Event Description

Summary : the differences in clinical and radiographic outcomes between 3-dimensional computer navigation (nav) and fluoroscopic-guided (fluo) minimally invasive transforaminal lumbar interbody fusion (mis-tlif) are currently unclear, with different studies showing different advantages of each technique.This study aimed to compare the clinical and radiographic outcomes of nav and fluo mis-tlif.Surgical procedures: mis-tlif using fluoroscopy patients were placed in the prone position on a radiolucent table.The lumbar area of interest was identified.A parasagittal incision was opened under a fluo image.Under an anteroposterior fluoroscopic view, the jamshidi needle was docked at the lateral border of the pedicle and advanced into the pedicle.Under lateral fluoroscopic view, kirschner wires were replaced through the jamshidi needles into the vertebral body.The same procedure was repeated at the contralateral site and lower vertebrae.Sequential dilation was performed through the paraspinal muscles.A table-mounted working tubular retractor (metrx ii system tube or mast quadrant system) was placed and docked under fluoroscopic guidance.Surgery was performed under an operating microscope.Following a total facetectomy, radical discectomy, and endplate preparation, the cage trial was serially inserted under fluoroscopic guidance until the proper size was attained.An appropriate sized capstone peek interbody spacer filled with mixed autogenous bone graft and demineralized bone matrix (dbm) was inserted.Percutaneous pedicle screws (cd horizon sextant ii) were placed into the pedicle guided by the kirschner wire.A subfascial rod was passed then radivac drain was placed, and the incision was closed.Mis-tlif using ct-guided navigation the patient was placed in the prone position on a radiolucent table.The navigation reference frame was embedded in the posterior superior iliac crest.The first spin was performed by the o-arm to create a 3d image, and the images were transferred automatically to the stealthstation system.Surgical instruments were registered for intraoperative navigation.The incision was made with the help of the navigation pointer and then serial dilators and insert tubular retractor on the side of decompression toward the facet joint.An operating microscope was used during laminotomy and discectomy.Capstone peek navigated trials with the green navlock tracker were inserted into the disc space until the desired disc space height is established.The appropriate sized interbody spacer cage, filled with mixed autogenous bone graft and dbm, was inserted into disc space.Then, the second o-arm spin was obtained for screw placement.Using an ¿awl-tipped tap,¿ penetrated through the pedicle into the vertebral body, percutaneous pedicle screws were inserted as determined from the visualized 3d image from the second spin.A contoured rod was passed underneath the fascia.A third 3d image was obtained for measuring the desired position.Reported events: ¿ 10 screws (2.3%) had medial penetration in the fluo group ¿ one screw in the fluo group showed grade 3 medial pedicle penetration, which required reoperation.¿ anterior cortex penetration was observed with 47 screws (17.4%) in the fluo group (grades 1 and 2), which was significantly higher than in the nav group((16 screws).

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14785182
• MDR Text Key: 303233401
• Report Number: 1030489-2022-00569
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_SXT
• Device Catalogue Number: MSB_UNK_SCRW_SXT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male