MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number MSB_UNK_LONGITUDE |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Pain (1994); Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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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.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 healthcare professional via manufacturer representative regarding patient with radicular symptom of l5 involved in posterior lumbar interbody fusion (plif) procedure on l5-s1 used in spinal therapy.It was reported during use, four screws on l2, s1, il were loose and lower limb symptoms occurred on l5.All the screws were removed, ps were added on l1-s1-il, plif was performed on l5-s.Revision surgery was performed on (b)(6) 2019.On (b)(6) 2018, pf was performed on l2-s1 and plif was performed on l4-5.On (b)(6) 2019, additional fixation was performed with two screws on each left and right of il.There was no delay in overall procedure time.Levels implanted: l1-s1-il.Reported additional treatment and patient hospitalization or prolongation of existing hospitalization was necessary to perform plif additionally on l5-s1.Received updated information that patient developed neurological symptoms after the re-surgery on (b)(6) 2020.Screws that were explanted was discarded by the hospital.Health damage in the patient was reported.On 2020-sep-29, received additional information that products with loose screw were at both sides of l2, both sides of s1, two pieces at il.Looseness was confirmed on a total of 6 screws.Therefore, the products were replaced.Lower extremity pain occurred after reoperation, the l2 vertebral body slipped posteriorly, and reoperation was performed on (b)(6) 2020.
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Event Description
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Information was received from healthcare professional via manufacturer representative regarding patient with radicular symptom of l5 involved in posterior lumbar interbody fusion (plif) procedure on l5-s1 used in spinal therapy.It was reported during use, four screws on l2, s1, il were loose and lower limb symptoms occurred on l5.All the screws were removed, ps were added on l1-s1-il, plif was performed on l5-s.Revision surgery was performed on (b)(6) 2019.On (b)(6) 2018, pf was performed on l2-s1 and plif was performed on l4-5.On (b)(6) 2019, additional fixation was performed with two screws on each left and right of il.There was no delay in overall procedure time.Levels implanted: l1-s1-il.Reported additional treatment and patient hospitalization or prolongation of existing hospitalization was necessary to perform plif additionally on l5-s1.Received updated information that patient developed neurological symptoms after the re-surgery on (b)(6) 2020.Screws that were explanted was discarded by the hospital.Health damage in the patient was reported.On 2020-sep-29, received additional information that, products with loose screw were at both sides of l2, both sides of s1, two pieces at il.Looseness was confirmed on a total of 6 screws.Therefore, the products were replaced.Lower extremity pain occurred after reoperation, the l2 vertebral body slipped posteriorly, and reoperation was performed on (b)(6) 2020.On (b)(6) 2021, received additional information that probably pain, and numbness have been reported.It was unknown whether pain and numbness occurred at implant site.Patient status might be recovered.
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Manufacturer Narrative
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Additional information: b5, g3, h6.Fdp code-c50672 and ime code-e20 no longer applicable to this 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.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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