MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Date 10/19/2018 |
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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Procedure: posterior lumbar interbody fusion (plif) level implanted:l3/5 pre-operative diagnosis: lumbar canal stenosis it was reported that post-op, after the operation, slight palsy happened to the patient.It was checked by ct image that the screw which was installed to l5 deviated towards spinal canal.Re-operation occurred due to screw deviation on (b)(6) 2018.Neurological symptom was reported to the patient as result of this event.
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Search Alerts/Recalls
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