MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
|
Back to Search Results |
|
Model Number MSB_UNK_SCRW_LG |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Event Description
|
Information was received from a manufacturer representative regarding a patient having l5 gill laminectomy and l4-5, s1 fusion for an indication of grade 2 l5-s1 spondylolisthesis.It was reported that the patient had initial surgery on (b)(6) 2011 and additional surgery was performed on (b)(6) 2014 for removal of failed instrumentation of lumbar spine and re-instrumentation with solera poly-axial pedicle screws and rods.The set screws were removed from the legacy instrumentation on the left side and the rod removed.Then the s1 screw was removed and found to be fractured at approximately two threads beyond the head of the screw. the pedicle screws were then removed.The s1 pedicle screw on the right had also fractured at the level of approximately two threads from the head of the screw.The patient then presented l5-s1 pseudoarthrosis and herniated disk syndrome at l4-5 and additional surgery of anterior lumbar exposure for l4-5, l5-s1 diskectomy and fusion, with replacement of cobalt chromium rods bilaterally was performed on (b)(6) 2016.A linear incision was made in the midline and carried down through the subcutaneous tissue to the spine.The instrumentation was exposed.Then, the set screws were removed out of the rods bilaterally and the rods at l4, l5 and s1 were removed.The underlying fusion appeared quite solid.We attempted to generate motion by toggling the screws and pulling on residual bony landmarks, however, no motion could be generated posteriorly.Because the posterior fusion was solid, i elected to replace the rods with new rods were tap-tighten then to the appropriate torque levels.There was no device malfunction reported.There were no further complications reported regarding the event.
|
|
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.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.
|
|
Search Alerts/Recalls
|
|
|