MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Model Number 7078396 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Information was received from a healthcare professional via manufacturer representative regarding a set screw used in spinal therapy.It was reported that the set screw of sai screw using ballast came off.Set screws on both sides of ballast came off.This was an incident of postoperative set screw dislodgement when using the ballast open screws.There were 4 set screws in one set and 2 of them have dislodged.The initial surgery was done on (b)(6) 2021 using solera5.5/6.6 ballast mrc in psf, fixed range t9/s2 therapy for lumbar posterior scoliosis.A revision surgery was scheduled on (b)(6) 2023 for re-fixing of ballast due to dislodged set screws; reinforcement with rods.The set screws have been removed at the hospital and iliac screws have been added on both sides.These are connected and reinforced with mrc connectors.The screws are expected to be returned.No patient symptoms were reported.No further complications were reported/anticipated.
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Manufacturer Narrative
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Radiographic image review: 1.Magnified lateral x-ray of posterior spinal hand wire.Implanted levels unclear.At the bottom of construct are of the set screws may be loose.2.Ct reconstruction - possible both set screws at bottom of construct are loose 3.Revision x-ray shows supplemental rods no complication seen.4.Lateral image of image 3.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.
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